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Hypothesis: The intraoperative administration of ketamine will result in a 30% reduction in opiate requirement following endometrial ablation surgery and the intraoperative administration of ketamine will result in a decreased time to meet discharge criteria in the PACU following endometrial ablation surgery.
The research question is "Does intraoperative administration of ketamine result in decreased postoperative opiate requirement and time to discharge from the postanesthesia recovery unit (PACU) following hysteroscopic endometrial ablation".
Preoperatively:
Subjects will be recruited up to 21days prior to the day of surgery. After informed consent is obtained, subjects will be randomly assigned to one of two groups:
Group A: Saline group Group B: 1% Ketamine group
A verbal rating scale (VRS) will be used to assess pain preoperatively. The patient will be asked to identify the severity of pain by indicating on a scale of 0-10 where 0 is "no pain" and 10 is "the worst pain imaginable".
Baseline Quality of Recovery will be obtained. (Appendix F)
Subjects will be randomized prior to surgery to either Group A or Group B. The randomization table is computer generated. There is a 50% allocation to each group.
Intraoperatively:
Standard anesthetic monitoring will be used including monitoring of processed EEG including either the bi-spectral index (BIS) or similar standard of care ASA monitor. A standardized intraoperative anesthetic plan will be utilized by the anesthesia personnel. (Appendix A). Study drug will be prepared and labeled in 10mL syringes by research personnel who will not be involved in the study assessments. Study drug will be administered on initial insertion of Novasure® device (Appendix B).
Postoperatively:
Pain scores in the PACU will be assessed using the VRS upon admission and every 30 minutes thereafter until discharge criteria are met.
Additionally, nausea, vomiting and retching episodes will be recorded using a VRS.
Postoperative analgesic and antiemetic therapy will be standardized and total amounts of these agents will be recorded Assessment of psychomimetic effects including sedation and agitation will be assess postoperatively prior to discharge using the Richmond Agitation/Sedation Scale (Appendix D).
Acute recovery will be assessed using the Modified Post Anesthesia Discharge Scoring System (MPADSS) (Appendix E). A score of 8 or greater will indicate discharge readiness. Time to fulfill discharge criteria will be recorded.
Any other adverse events and medications required will be recorded. These data will be recorded by research personnel who will be blinded to the study group assignments.
Subjects will be contacted by telephone 24 hours after surgery to assess post-discharge quality of recovery (Appendix F).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Saline group | Placebo Comparator | Group A: Saline group , infusion of saline intravenously |
|
| Group B: 1% Ketamine group | Active Comparator | Group B: Infusion of ketamine 1% intravenously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group A: Saline Group | Drug | Saline continuous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Recovery Score Post Operative at 24 Hours | Quality of recovery 40 score at 24 hours after the surgical procedure. 40 being a poor recovery and 200 being a good recovery. | 24 hours post operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shireen Ahmad, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States | ||
| Prentice Women's Hosptial |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6281085 | Background | Schenker JG, Margalioth EJ. Intrauterine adhesions: an updated appraisal. Fertil Steril. 1982 May;37(5):593-610. doi: 10.1016/s0015-0282(16)46268-0. No abstract available. | |
| 10908775 | Background | Jansen FW, Vredevoogd CB, van Ulzen K, Hermans J, Trimbos JB, Trimbos-Kemper TC. Complications of hysteroscopy: a prospective, multicenter study. Obstet Gynecol. 2000 Aug;96(2):266-70. doi: 10.1016/s0029-7844(00)00865-6. |
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Date of recruitment 03/15/2010-02/14/2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: Saline Group | Group A: Saline group , infusion of saline intravenously Group A: Saline Group: Saline continuous infusion |
| FG001 | Group B: 1% Ketamine Group | Group B: Infusion of ketamine 1% intravenously Group B: 1% Ketamine group: Administration of 1% ketamine intravenously. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A: Saline Group | Group A: Saline group , infusion of saline intravenously Group A: Saline Group: Saline continuous infusion |
| BG001 | Group B: 1% Ketamine Group | Group B: Infusion of ketamine 1% intravenously Group B: 1% Ketamine group: Administration of 1% ketamine intravenously. |
| 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 | Quality of Recovery Score Post Operative at 24 Hours | Quality of recovery 40 score at 24 hours after the surgical procedure. 40 being a poor recovery and 200 being a good recovery. | Posted | Mean | Standard Deviation | units on scale | 24 hours post operative |
|
1 Hour post operative
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A: Saline Group | Group A: Saline group , infusion of saline intravenously Group A: Saline Group: Saline continuous infusion |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment | Nausea 60 minutes post operative |
Study was terminated early.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shireen Ahmad, M.D. | Northwestern University | 321-472-3585 | sah704@northwestern.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Group B: 1% Ketamine group | Drug | Administration of 1% ketamine intravenously. |
|
|
| Chicago |
| Illinois |
| 60611 |
| United States |
| 10856489 | Background | Wong AY, Wong K, Tang LC. Stepwise pain score analysis of the effect of local lignocaine on outpatient hysteroscopy: a randomized, double-blind, placebo-controlled trial. Fertil Steril. 2000 Jun;73(6):1234-7. doi: 10.1016/s0015-0282(00)00498-2. |
| 10087415 | Background | Lau WC, Ho RY, Tsang MK, Yuen PM. Patient's acceptance of outpatient hysteroscopy. Gynecol Obstet Invest. 1999;47(3):191-3. doi: 10.1159/000010092. |
| 10648742 | Background | De Iaco P, Marabini A, Stefanetti M, Del Vecchio C, Bovicelli L. Acceptability and pain of outpatient hysteroscopy. J Am Assoc Gynecol Laparosc. 2000 Feb;7(1):71-5. doi: 10.1016/s1074-3804(00)80012-2. |
| 18716494 | Background | MacPherson RD, Woods D, Penfold J. Ketamine and midazolam delivered by patient-controlled analgesia in relieving pain associated with burns dressings. Clin J Pain. 2008 Sep;24(7):568-71. doi: 10.1097/AJP.0b013e31816cdb20. |
| 6892475 | Background | White PF, Way WL, Trevor AJ. Ketamine--its pharmacology and therapeutic uses. Anesthesiology. 1982 Feb;56(2):119-36. doi: 10.1097/00000542-198202000-00007. No abstract available. |
| 9447860 | Background | Bowdle TA, Radant AD, Cowley DS, Kharasch ED, Strassman RJ, Roy-Byrne PP. Psychedelic effects of ketamine in healthy volunteers: relationship to steady-state plasma concentrations. Anesthesiology. 1998 Jan;88(1):82-8. doi: 10.1097/00000542-199801000-00015. |
| 11682390 | Background | Deng XM, Xiao WJ, Luo MP, Tang GZ, Xu KL. The use of midazolam and small-dose ketamine for sedation and analgesia during local anesthesia. Anesth Analg. 2001 Nov;93(5):1174-7. doi: 10.1097/00000539-200111000-00023. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 0 |
| 12 |
| 3 |
| 12 |
| EG001 | Group B: 1% Ketamine Group | Group B: Infusion of ketamine 1% intravenously Group B: 1% Ketamine group: Administration of 1% ketamine intravenously. | 0 | 9 | 0 | 9 |
|
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| D017670 |
| Sodium Compounds |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |