Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Nervous, anxiety, fear and other psychological reactions always appears in parturients during cesarean section. This study intends to investigate the effectiveness and safety of dexmedetomidine combined with butorphanol tartrate for postoperative analgesia and breastfeeding after caesarean section.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Placebo Comparator | The placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min and receive 1mg butorphanol after delivery. Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min. |
|
| Dexmedetomidine 0.03ug/kg/h group | Experimental | This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min and 1mg butorphanol tartrate after delivery. Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min. |
|
| Dexmedetomidine 0.05ug/kg/h group | Experimental | This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min and 1mg butorphanol tartrate after delivery. Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min. |
|
| Dexmedetomidine 0.08ug/kg/h group | Experimental | This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min and 1mg butorphanol tartrate after delivery. Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal Saline | Drug | Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest | visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS at rest was assessed when the patient was in supine position | 6h after cesarean section. |
| Measure | Description | Time Frame |
|---|---|---|
| Relative Infant Dose (RID) of Dexmedetomidine | Relative infant dose (RID) =Dose (infant, mg•kg-1•day-1) /Dose (mother, mg•kg-1•day-1) μg·kg-1·h-1. The Dose (infant) in mg•kg-1 is calculated by multiplying the concentration of the drug in breast milk by the volume of breast milk consumed daily (about 150 mL•kg-1). | 48h after cesarean section. |
Not provided
Inclusion Criteria:
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital with Nanjing Medical University | Nanjing | Jiangsu | 210029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10927999 | Result | Desborough JP. The stress response to trauma and surgery. Br J Anaesth. 2000 Jul;85(1):109-17. doi: 10.1093/bja/85.1.109. No abstract available. | |
| 11020770 | Result | Perkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000 Oct;93(4):1123-33. doi: 10.1097/00000542-200010000-00038. No abstract available. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
not meeting inclusion criteria (n=39)
declined to participate , n=14
other reasons, n=3
Parturients (>18 and <45 years old) with a singleton pregnancy admitted to our institute who underwent elective caesarean delivery under epidural anaesthesia were recruited in this study between February 2017 and October 2017.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group C | The placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min. Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min. Normal Saline: Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section. |
| FG001 | Group D1 | This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min. Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min. Dexmedetomidine 0.03ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section. |
| FG002 | Group D2 | This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min. Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min. Dexmedetomidine 0.05ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section. |
| FG003 | Group D3 | This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min. Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min. Dexmedetomidine 0.08ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | The placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min. Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min. Normal Saline: Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest | visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS at rest was assessed when the patient was in supine position | Posted | Mean | Standard Deviation | units on a scale | 6h after cesarean section. |
|
Every 6 hours post cesarean section, up to 48 hours in total.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group C | The placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min. Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min. Normal Saline: Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shijiang Liu, Dr. Mei Gao | The First Affiliated Hospital of Nanjing Medical University | +862568303569 | liushijiang1983@hotmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 21, 2019 | Dec 21, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Dexmedetomidine 0.03ug/kg/h | Drug | Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section. |
|
|
| Dexmedetomidine 0.05ug/kg/h | Drug | Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section. |
|
|
| Dexmedetomidine 0.08ug/kg/h | Drug | Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section. |
|
|
| Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest | visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS at rest was assessed when the patient was in supine position | 12h after cesarean section. |
| Ramsay Sedation Score(RSS) | Sedation intensity measured with RSS is recorded at the 6, 12 24 and 48 h after cesarean section. Sedation was assessed by the Ramsay Sedation Scores (RSS) (1, anxious patient; 2, cooperative and tranquil; 3, responding to command; 4, brisk response to stimulus; 5, sluggish response to stimulus; 6, no response to stimulus). | 6h after cesarean section. |
| The Degree of Satisfaction | The degree of satisfaction (0, very satisfied; 1, satisfied; 2, moderately satisfied; 3, not satisfied) was evaluated at 48 h after surgery. The number of overall satisfied patients (satisfied and very satisfied) is reported. | 48h after cesarean section. |
| Number of Participants That Experienced Nausea or Vomiting | Total times during 48h after cesarean section. | 48h after cesarean section. |
| Ramsay Sedation Score(RSS) | Sedation intensity measured with RSS is recorded at the 6, 12, 24, and 48 h after cesarean section. Sedation was assessed by the Ramsay Sedation Scores (RSS) (1, anxious patient; 2, cooperative and tranquil; 3, responding to command; 4, brisk response to stimulus; 5, sluggish response to stimulus; 6, no response to stimulus). | 12h after cesarean section. |
| Ramsay Sedation Score(RSS) | Sedation intensity measured with RSS is recorded at the 6, 12, 24, and 48 h after cesarean section. Sedation was assessed by the Ramsay Sedation Scores (RSS) (1, anxious patient; 2, cooperative and tranquil; 3, responding to command; 4, brisk response to stimulus; 5, sluggish response to stimulus; 6, no response to stimulus). | 24h after cesarean section. |
| Ramsay Sedation Score(RSS) | Sedation intensity measured with RSS is recorded at the 6, 12, 24, and 48 h after cesarean section. Sedation was assessed by the Ramsay Sedation Scores (RSS) (1, anxious patient; 2, cooperative and tranquil; 3, responding to command; 4, brisk response to stimulus; 5, sluggish response to stimulus; 6, no response to stimulus). | 48h after cesarean section. |
| Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest | visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS at rest was assessed when the patient was in supine position | 24h after cesarean section. |
| Postoperative Pain Score (Visual Analogue Scale, VAS) | visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS at rest was assessed when the patient was in supine position | 48h after cesarean section. |
| Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement | visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS on movement was assessed when patients changed from supine to lateral position. | 6h after cesarean section. |
| Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement | visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS on movement was assessed when patients changed from supine to lateral position. | 12h after cesarean section. |
| Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement | visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS on movement was assessed when patients changed from supine to lateral position. | 24h after cesarean section. |
| Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement | visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS on movement was assessed when patients changed from supine to lateral position. | 48h after cesarean section. |
| Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping | visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS-C was assessed when the patient required oxytocin after surgery in supine position | 6h after cesarean section. |
| Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping | visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS-C was assessed when the patient required oxytocin after surgery in supine position | 12h after cesarean section. |
| Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping | visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS-C was assessed when the patient required oxytocin after surgery in supine position | 24h after cesarean section. |
| 27870738 | Result | Kainu JP, Halmesmaki E, Korttila KT, Sarvela PJ. Persistent Pain After Cesarean Delivery and Vaginal Delivery: A Prospective Cohort Study. Anesth Analg. 2016 Dec;123(6):1535-1545. doi: 10.1213/ANE.0000000000001619. |
| 18818022 | Result | Eisenach JC, Pan PH, Smiley R, Lavand'homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. doi: 10.1016/j.pain.2008.07.011. Epub 2008 Sep 24. |
| 18987053 | Result | Lin TF, Yeh YC, Lin FS, Wang YP, Lin CJ, Sun WZ, Fan SZ. Effect of combining dexmedetomidine and morphine for intravenous patient-controlled analgesia. Br J Anaesth. 2009 Jan;102(1):117-22. doi: 10.1093/bja/aen320. Epub 2008 Nov 5. |
| 22436955 | Result | Jakob SM, Ruokonen E, Grounds RM, Sarapohja T, Garratt C, Pocock SJ, Bratty JR, Takala J; Dexmedetomidine for Long-Term Sedation Investigators. Dexmedetomidine vs midazolam or propofol for sedation during prolonged mechanical ventilation: two randomized controlled trials. JAMA. 2012 Mar 21;307(11):1151-60. doi: 10.1001/jama.2012.304. |
| 23706726 | Result | Schnabel A, Meyer-Friessem CH, Reichl SU, Zahn PK, Pogatzki-Zahn EM. Is intraoperative dexmedetomidine a new option for postoperative pain treatment? A meta-analysis of randomized controlled trials. Pain. 2013 Jul;154(7):1140-9. doi: 10.1016/j.pain.2013.03.029. Epub 2013 Mar 27. |
| 28854538 | Result | Colin PJ, Hannivoort LN, Eleveld DJ, Reyntjens KMEM, Absalom AR, Vereecke HEM, Struys MMRF. Dexmedetomidine pharmacokinetic-pharmacodynamic modelling in healthy volunteers: 1. Influence of arousal on bispectral index and sedation. Br J Anaesth. 2017 Aug 1;119(2):200-210. doi: 10.1093/bja/aex085. |
| 14693611 | Result | Arain SR, Ruehlow RM, Uhrich TD, Ebert TJ. The efficacy of dexmedetomidine versus morphine for postoperative analgesia after major inpatient surgery. Anesth Analg. 2004 Jan;98(1):153-158. doi: 10.1213/01.ANE.0000093225.39866.75. |
| 26266386 | Result | Ren C, Chi M, Zhang Y, Zhang Z, Qi F, Liu Z. Dexmedetomidine in Postoperative Analgesia in Patients Undergoing Hysterectomy: A CONSORT-Prospective, Randomized, Controlled Trial. Medicine (Baltimore). 2015 Aug;94(32):e1348. doi: 10.1097/MD.0000000000001348. |
| 27977073 | Result | Orbach-Zinger S, Fireman S, Ben-Haroush A, Karoush T, Klein Z, Mazarib N, Artyukh A, Chen R, Ioscovich A, Eidelman LA, Landau R. Preoperative sleep quality predicts postoperative pain after planned caesarean delivery. Eur J Pain. 2017 May;21(5):787-794. doi: 10.1002/ejp.980. Epub 2016 Dec 15. |
| 15505441 | Result | Hsu YW, Cortinez LI, Robertson KM, Keifer JC, Sum-Ping ST, Moretti EW, Young CC, Wright DR, Macleod DB, Somma J. Dexmedetomidine pharmacodynamics: part I: crossover comparison of the respiratory effects of dexmedetomidine and remifentanil in healthy volunteers. Anesthesiology. 2004 Nov;101(5):1066-76. doi: 10.1097/00000542-200411000-00005. |
| 22681971 | Result | El-Tahan MR, Mowafi HA, Al Sheikh IH, Khidr AM, Al-Juhaiman RA. Efficacy of dexmedetomidine in suppressing cardiovascular and hormonal responses to general anaesthesia for caesarean delivery: a dose-response study. Int J Obstet Anesth. 2012 Jul;21(3):222-9. doi: 10.1016/j.ijoa.2012.04.006. Epub 2012 Jun 7. |
| 24463478 | Result | Nie Y, Liu Y, Luo Q, Huang S. Effect of dexmedetomidine combined with sufentanil for post-caesarean section intravenous analgesia: a randomised, placebo-controlled study. Eur J Anaesthesiol. 2014 Apr;31(4):197-203. doi: 10.1097/EJA.0000000000000011. |
| 19464877 | Result | Sia AT, Sng BL. Intravenous dexmedetomidine for obstetric anaesthesia and analgesia: converting a challenge into an opportunity? Int J Obstet Anesth. 2009 Jul;18(3):204-6. doi: 10.1016/j.ijoa.2009.02.008. Epub 2009 May 22. No abstract available. |
| 19122562 | Result | Abu-Halaweh SA, Al Oweidi AK, Abu-Malooh H, Zabalawi M, Alkazaleh F, Abu-Ali H, Ramsay MA. Intravenous dexmedetomidine infusion for labour analgesia in patient with preeclampsia. Eur J Anaesthesiol. 2009 Jan;26(1):86-7. doi: 10.1097/EJA.0b000e000000f3fb. No abstract available. |
| 27856195 | Result | Nakanishi R, Yoshimura M, Suno M, Yamamoto K, Ito H, Uchimine Y, Toriumi T, Kurosawa A, Sugawara A, Kunisawa T. Detection of dexmedetomidine in human breast milk using liquid chromatography-tandem mass spectrometry: Application to a study of drug safety in breastfeeding after Cesarean section. J Chromatogr B Analyt Technol Biomed Life Sci. 2017 Jan 1;1040:208-213. doi: 10.1016/j.jchromb.2016.11.015. Epub 2016 Nov 10. |
| 28687146 | Result | Yoshimura M, Kunisawa T, Suno M, Sugawara A, Kurosawa A, Nakanishi R, Aoki K, Toriumi T. Intravenous dexmedetomidine for cesarean delivery and its concentration in colostrum. Int J Obstet Anesth. 2017 Nov;32:28-32. doi: 10.1016/j.ijoa.2017.05.002. Epub 2017 May 10. |
| 10702460 | Result | Hall JE, Uhrich TD, Barney JA, Arain SR, Ebert TJ. Sedative, amnestic, and analgesic properties of small-dose dexmedetomidine infusions. Anesth Analg. 2000 Mar;90(3):699-705. doi: 10.1097/00000539-200003000-00035. |
| 28449631 | Result | Wang C, Liu S, Han C, Yu M, Hu Y, Liu C. Effect and placental transfer of dexmedetomidine during caesarean section under epidural anaesthesia. J Int Med Res. 2017 Jun;45(3):964-972. doi: 10.1177/0300060517698330. Epub 2017 Apr 28. |
| 28587365 | Result | Jiang W, Wang Q, Xu M, Li Y, Yang R, Song X, Duan H, Zhang P. Assessment of different loading doses of dexmedetomidine hydrochloride in preventing adverse reaction after combined spinal-epidural anesthesia. Exp Ther Med. 2017 Jun;13(6):2946-2950. doi: 10.3892/etm.2017.4335. Epub 2017 Apr 13. |
| 28183547 | Result | Chen Z, Tang R, Zhang R, Jiang Y, Liu Y. Effects of dexmedetomidine administered for postoperative analgesia on sleep quality in patients undergoing abdominal hysterectomy. J Clin Anesth. 2017 Feb;36:118-122. doi: 10.1016/j.jclinane.2016.10.022. Epub 2016 Dec 1. |
| 21563142 | Result | Deussen AR, Ashwood P, Martis R. Analgesia for relief of pain due to uterine cramping/involution after birth. Cochrane Database Syst Rev. 2011 May 11;(5):CD004908. doi: 10.1002/14651858.CD004908.pub2. |
| 23922910 | Result | Kelly LE, Chaudhry SA, Rieder MJ, 't Jong G, Moretti ME, Lausman A, Ross C, Berger H, Carleton B, Hayden MR, Madadi P, Koren G. A clinical tool for reducing central nervous system depression among neonates exposed to codeine through breast milk. PLoS One. 2013 Jul 29;8(7):e70073. doi: 10.1371/journal.pone.0070073. Print 2013. |
| 25927109 | Result | Chow CK, Koren G. Sedating drugs and breastfeeding. Can Fam Physician. 2015 Mar;61(3):241-3. |
| 26457856 | Result | Newton ER, Hale TW. Drugs in Breast Milk. Clin Obstet Gynecol. 2015 Dec;58(4):868-84. doi: 10.1097/GRF.0000000000000142. |
| 14616431 | Result | Anttila M, Penttila J, Helminen A, Vuorilehto L, Scheinin H. Bioavailability of dexmedetomidine after extravascular doses in healthy subjects. Br J Clin Pharmacol. 2003 Dec;56(6):691-3. doi: 10.1046/j.1365-2125.2003.01944.x. |
| 24451212 | Result | Lind JN, Perrine CG, Li R. Relationship between use of labor pain medications and delayed onset of lactation. J Hum Lact. 2014 May;30(2):167-73. doi: 10.1177/0890334413520189. Epub 2014 Jan 22. |
| 15795144 | Result | Sia AT, Kwek K, Yeo GS. The in vitro effects of clonidine and dexmedetomidine on human myometrium. Int J Obstet Anesth. 2005 Apr;14(2):104-7. doi: 10.1016/j.ijoa.2004.11.004. |
| 25652672 | Result | Yu M, Han C, Jiang X, Wu X, Yu L, Ding Z. Effect and Placental Transfer of Dexmedetomidine During Caesarean Section Under General Anaesthesia. Basic Clin Pharmacol Toxicol. 2015 Sep;117(3):204-8. doi: 10.1111/bcpt.12389. Epub 2015 Mar 4. |
| Protocol Violation |
|
| BG001 | Dexmedetomidine 0.03ug/kg/h | This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min. Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min. Dexmedetomidine 0.03ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section. |
| BG002 | Dexmedetomidine 0.05ug/kg/h | This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min. Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min. Dexmedetomidine 0.05ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section. |
| BG003 | Dexmedetomidine 0.08ug/kg/h | This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min. Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min. Dexmedetomidine 0.08ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min. Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min. Dexmedetomidine 0.03ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section. |
| OG002 | Group D2 | This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min. Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min. Dexmedetomidine 0.05ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section. |
| OG003 | Group D3 | This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min. Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min. Dexmedetomidine 0.08ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section. |
|
|
|
| Secondary | Relative Infant Dose (RID) of Dexmedetomidine | Relative infant dose (RID) =Dose (infant, mg•kg-1•day-1) /Dose (mother, mg•kg-1•day-1) μg·kg-1·h-1. The Dose (infant) in mg•kg-1 is calculated by multiplying the concentration of the drug in breast milk by the volume of breast milk consumed daily (about 150 mL•kg-1). | Posted | Mean | Standard Deviation | percentage of one hundred | 48h after cesarean section. |
|
|
|
| Secondary | Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest | visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS at rest was assessed when the patient was in supine position | Posted | Mean | Standard Deviation | score on a scale | 12h after cesarean section. |
|
|
|
| Secondary | Ramsay Sedation Score(RSS) | Sedation intensity measured with RSS is recorded at the 6, 12 24 and 48 h after cesarean section. Sedation was assessed by the Ramsay Sedation Scores (RSS) (1, anxious patient; 2, cooperative and tranquil; 3, responding to command; 4, brisk response to stimulus; 5, sluggish response to stimulus; 6, no response to stimulus). | Posted | Mean | Standard Deviation | score on a scale | 6h after cesarean section. |
|
|
|
| Secondary | The Degree of Satisfaction | The degree of satisfaction (0, very satisfied; 1, satisfied; 2, moderately satisfied; 3, not satisfied) was evaluated at 48 h after surgery. The number of overall satisfied patients (satisfied and very satisfied) is reported. | Posted | Count of Participants | Participants | 48h after cesarean section. |
|
|
|
| Secondary | Number of Participants That Experienced Nausea or Vomiting | Total times during 48h after cesarean section. | Posted | Number | participants | 48h after cesarean section. |
|
|
|
| Secondary | Ramsay Sedation Score(RSS) | Sedation intensity measured with RSS is recorded at the 6, 12, 24, and 48 h after cesarean section. Sedation was assessed by the Ramsay Sedation Scores (RSS) (1, anxious patient; 2, cooperative and tranquil; 3, responding to command; 4, brisk response to stimulus; 5, sluggish response to stimulus; 6, no response to stimulus). | Posted | Mean | Standard Deviation | score on a scale | 12h after cesarean section. |
|
|
|
| Secondary | Ramsay Sedation Score(RSS) | Sedation intensity measured with RSS is recorded at the 6, 12, 24, and 48 h after cesarean section. Sedation was assessed by the Ramsay Sedation Scores (RSS) (1, anxious patient; 2, cooperative and tranquil; 3, responding to command; 4, brisk response to stimulus; 5, sluggish response to stimulus; 6, no response to stimulus). | Posted | Mean | Standard Deviation | score on a scale | 24h after cesarean section. |
|
|
|
| Secondary | Ramsay Sedation Score(RSS) | Sedation intensity measured with RSS is recorded at the 6, 12, 24, and 48 h after cesarean section. Sedation was assessed by the Ramsay Sedation Scores (RSS) (1, anxious patient; 2, cooperative and tranquil; 3, responding to command; 4, brisk response to stimulus; 5, sluggish response to stimulus; 6, no response to stimulus). | Posted | Mean | Standard Deviation | score on a scale | 48h after cesarean section. |
|
|
|
| Secondary | Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest | visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS at rest was assessed when the patient was in supine position | Posted | Mean | Standard Deviation | score on a scale | 24h after cesarean section. |
|
|
|
| Secondary | Postoperative Pain Score (Visual Analogue Scale, VAS) | visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS at rest was assessed when the patient was in supine position | Posted | Mean | Standard Deviation | score on a scale | 48h after cesarean section. |
|
|
|
| Secondary | Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement | visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS on movement was assessed when patients changed from supine to lateral position. | Posted | Mean | Standard Deviation | score on a scale | 6h after cesarean section. |
|
|
|
| Secondary | Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement | visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS on movement was assessed when patients changed from supine to lateral position. | Posted | Mean | Standard Deviation | score on a scale | 12h after cesarean section. |
|
|
|
| Secondary | Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement | visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS on movement was assessed when patients changed from supine to lateral position. | Posted | Mean | Standard Deviation | score on a scale | 24h after cesarean section. |
|
|
|
| Secondary | Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement | visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS on movement was assessed when patients changed from supine to lateral position. | Posted | Mean | Standard Deviation | score on a scale | 48h after cesarean section. |
|
|
|
| Secondary | Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping | visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS-C was assessed when the patient required oxytocin after surgery in supine position | Posted | Mean | Standard Deviation | score on a scale | 6h after cesarean section. |
|
|
|
| Secondary | Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping | visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS-C was assessed when the patient required oxytocin after surgery in supine position | Posted | Mean | Standard Deviation | score on a scale | 12h after cesarean section. |
|
|
|
| Secondary | Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping | visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS-C was assessed when the patient required oxytocin after surgery in supine position | Posted | Mean | Standard Deviation | score on a scale | 24h after cesarean section. |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 1 |
| 28 |
| EG001 | Group D1 | This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min. Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min. Dexmedetomidine 0.03ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section. | 0 | 29 | 0 | 29 | 2 | 29 |
| EG002 | Group D2 | This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min. Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min. Dexmedetomidine 0.05ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section. | 0 | 29 | 0 | 29 | 1 | 29 |
| EG003 | Group D3 | This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min. Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min. Dexmedetomidine 0.08ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section. | 0 | 28 | 0 | 28 | 1 | 28 |
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |