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Several modalities have been studied to prevent coughing during emergence, including extubation in a deep plane of anesthesia but have proved to be unreliable. So far, no reliable method is recommended as standard of care. The advantages of administering tramadol includes a long duration of action, rapid recovery, limited depression of respiratory function and no effect on platelet makes it a safe medication to use for neurosurgical patients after craniotomy. The primary objective of the study is to observe the effect of single dose of tramadol (1mg/kg) administered 45 minutes before extubation on hemodynamic response (measurement of B.P and H.R) during extubation.
Extubation after intracranial tumor surgery is desirable in order to make an early diagnosis of intracranial complications. Extubation however, may be associated with haemodynamic and metabolic changes e.g. agitation, increased oxygen consumption, catecholamine secretion, hypercapnia and systemic hypertension.
These changes cause cerebral hyperemia, intracranial hypertension leading to cerebral oedema or haemorrhage, thus it is important to have smooth extubation with minimal haemodynamic and metabolic effects.
Incidence of coughing on emergence from general anesthesia ranges from 38% to 96%. This may also result in postoperative intracranial hemorrhage, intracranial hypertension, cerebral edema or intraocular hypertension.This can be detrimental in neurosurgery.
Several modalities have been studied to prevent coughing during emergence, including extubation in a deep plane of anesthesia but have proved to be unreliable. So far, no reliable method is recommended as standard of care.
Tramadol, a synthetic opioid of the aminocyclohexanes group, is a centrally acting opioid analgesic that is used to treat moderate-to-severe pain and has an inhibitory effect on M1 and M3 muscarinic receptors. It also reduces the incidence of cough and improves extubation quality, and provides more stable haemodynamics during emergence. It neither causes respiratory depression, nor affects intracranial pressure (ICP) and cerebral perfusion pressure (CPP). Other potential advantage of administering tramadol includes a long duration of action, rapid recovery, limited depression of respiratory function and no effect on platelets thus making it a safe medication to use for neurosurgical patients after craniotomy. The onset of effect following a single dose is 3 to 5 minutes with peak effect at 45 minutes.
Aim of doing this study is to observe the effect of a single dose of tramadol on quality of tracheal extubation as judged by incidence of coughing and haemodynamic changes at emergence from anesthesia.
OBJECTIVE:
Primary Objective: To observe the effect of single dose of tramadol (1mg/kg) administered 45 minutes before extubation on haemodynamic response (measurement of B.P and H.R) during extubation.
Secondary Objective: To measure the quality of emergence from general anaesthesia by measuring the frequency of cough, laryngospasm and episodes of desaturation.
OPERATIONAL DEFINITION:
Emergence Period: This will be defined as the time from the recovery of spontaneous breathing after giving reversal to tracheal extubation.
Quality of emergence: Good quality emergence will be defined as extubation not associated with coughing, bucking, tachycardia, hypertension, laryngospasm or bronchospasm.
Tachycardia and hypertension: Rise in heart rate and blood pressure more than 20% from baseline value.
Extubation response: Physiological response related to blood pressure and heart rate during extubation of trachea is called extubation response,
HYPOTHESIS:
Tramadol obtunds haemodynamic and cough response to extubation and thus results in good quality emergence after supratentorial craniotomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tramadol | Experimental | Injection Tramadol 100mg diluted in 10 cc syringe (10mg/ml) to be given as 1mg/kg or (1ml/10kg) via intravenous route, once, at the time of dura closure |
|
| Placebo | Placebo Comparator | 0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injection Tramadol | Drug |
|
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Haemodynamic Parameters at the Time of Emergence and Postextubation | Systolic blood pressure will be recorded at 1 minute before giving the reversal (glycopyrolate and neostigmine) and then 1,2,5,10,20,30 minutes ,1,2,4 and 6 hours after extubation. If values of blood pressure rise more than 20% from baseline values injection Metoprolol 1mg (beta blocker) bolus will be used and titrated according to response. The study will end at 6 hours post extubation. | Systolic BP from the time of extubation till 6 hours post operatively |
| Haemodynamic Parameters at the Time of Emergence and Postextubation | Heart rate will be recorded at 1 minute before giving the reversal (glycopyrolate and neostigmine) and then 1,2,5,10,20,30 minutes ,1,2,4 and 6 hours after extubation. If haemodynamic values of heart rate rise more than 20% from baseline values injection Metoprolol 1mg (beta blocker) bolus will be used and titrated according to response. The study will end at 6 hours post extubation. | HR from the time of extubation till 6 hours post operatively |
| Haemodynamic Parameters at the Time of Emergence and Postextubation | Diastolic blood pressure will be recorded at 1 minute before giving the reversal (glycopyrolate and neostigmine) and then 1,2,5,10,20,30 minutes ,1,2,4 and 6 hours after extubation. If values of blood pressure rise more than 20% from baseline values injection Metoprolol 1mg (beta blocker) bolus will be used and titrated according to response. The study will end at 6 hours post extubation. | Diastolic BP from the time of extubation till 6 hours post operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | Cough will be described on following scale 5 = No coughing or straining, 4 = Very smooth minimal coughing, 3 = Moderate coughing, 2 = Marked coughing or straining, 1 = Poor extubation Cough will be recorded on the above mentioned scale by resident/consultant at following time intervals of emergence
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Asma A Salam, MCPS, FCPS | Aga Khan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aga Khan University | Karachi | Sindh | 74800 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8638792 | Background | Mikawa K, Nishina K, Maekawa N, Obara H. Attenuation of cardiovascular responses to tracheal extubation: verapamil versus diltiazem. Anesth Analg. 1996 Jun;82(6):1205-10. doi: 10.1097/00000539-199606000-00018. | |
| 22089326 | Background | Lin BF, Ju DT, Cherng CH, Hung NK, Yeh CC, Chan SM, Wu CT. Comparison between intraoperative fentanyl and tramadol to improve quality of emergence. J Neurosurg Anesthesiol. 2012 Apr;24(2):127-32. doi: 10.1097/ANA.0b013e31823c4a24. |
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A total of 80 patients were enrolled and selected to randomize. 39 patients in Tramadol group and 41 patients in placebo group.79 patients completed the study as one patient in tramadol group dropped out due to change/ modification in his surgical procedure.
Over a period of two years, 2016 and 2017
Patients were recruited in the study during the preoperative anesthesia evaluation either at the preoperative clinic or from the ward after admission.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tramadol | Injection Tramadol 100mg diluted in 10 cc syringe (10mg/ml) to be given as 1mg/kg or (1ml/10kg) via intravenous route, once, at the time of dura closure Injection Tramadol |
| FG001 | Placebo | 0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure placebo: 0.9% Normal saline in 10 ml syringe |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tramadol | Injection Tramadol 100mg diluted in 10 cc syringe (10mg/ml) to be given as 1mg/kg or (1ml/10kg) via intravenous route, once, at the time of dura closure |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Haemodynamic Parameters at the Time of Emergence and Postextubation | Systolic blood pressure will be recorded at 1 minute before giving the reversal (glycopyrolate and neostigmine) and then 1,2,5,10,20,30 minutes ,1,2,4 and 6 hours after extubation. If values of blood pressure rise more than 20% from baseline values injection Metoprolol 1mg (beta blocker) bolus will be used and titrated according to response. The study will end at 6 hours post extubation. | Posted | Mean | Standard Deviation | mm Hg | Systolic BP from the time of extubation till 6 hours post operatively |
|
Event occured in the immediate postoperative period
Patient had low GCS of 8 in recovery room, and got reintubated within 2 hours of extubation, post craniotomy. After treatment with desmopressin for Diabetes insipidus patient recovered and was extubated in ICU within 48 hours.
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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 | Tramadol | Injection Tramadol 100mg diluted in 10 cc syringe (10mg/ml) to be given as 1mg/kg once at the time of dura closure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| low conscious levels in post operative period | Endocrine disorders | Placebo | Systematic Assessment | One patient had a GCS of 8 after extubation and was shifted to ICU after getting reintubated. Reason was diabetes insipidus which was treated with Desmopressin.GCS improved later and the patient was extubated in 48 hours |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Asma Abdus Salam | Aga Khan University | +92-21-34864715 | 4639 | asma.salam.azhar@gmail.com |
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| 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 | Apr 5, 2016 | Jul 21, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D014147 | Tramadol |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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| Other |
0.9% Normal saline in 10 ml syringe |
|
|
| Cough at the time of emergence |
| Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Laryngospasm and Bronchospasm. | If there is any episode of bronchospasm or laryngospasm, it will be noted if it occured during emergence and for 6 hours post operatively. Absence of it will be considered as smooth emergence | at the time of extubation till 6 hours postoperatively |
| Measure the Quality of Emergence From General Anaesthesia by Measuring Sedation Score | If there is any episode of sedation it will be noted if it occurs during emergence and for 6 hours post operatively. Absence of it will be considered as smooth emergence. sedation score will be used as 0= no sedation, 1= mildly sedated (eye opening on verbal commands), 2= moderately sedated ( awakens on giving pain), 3= deeply sedated ( not waking up even on pain) | at the time of extubation till 6 hours postoperatively |
| Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring PONV | Post operative nausea vomiting will be recorded at RR, 2, 4 and 6 hours postoperatively. If there is any episode of PONV it will be noted. Absence of it will be considered as smooth emergence | at Recovery Room , 2, 4 and 6 hours postoperatively |
| Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring Convulsions | Convulsions will be recorded at Recovery Room, 2, 4 and 6 hours postoperatively.If there is any episode of convulsion, it will be noted. Absence of it will be considered as smooth emergence. | at Recovery Room, 2, 4 and 6 hours postoperatively |
| Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS | Post operative Glasgow Coma Scale (GCS) will be recorded at Recovery Room, 2, 4 and 6 hours postoperatively. If there is any deterioration in GCS less than 8/15, Patients will be intubated. GCS categories <8 Low GCS 9-12 Intermediate GCS 13-15 Full GCS | at Recovery Room, 2, 4 and 6 hours postoperatively |
| Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Mointoring Requirement of Analgesia | Requirement of analgesia will be recorded at recovery room, 2, 4 and 6 hours postoperatively. If there is any need of analgesic, it will be noted and will be considered as one of the determinants of poor quality of emergence. | At Recovery room, 2, 4 and 6 hours postoperatively |
| Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Episodes of Denaturation | If there is any episodes of denaturation (Oxygen saturation <92%), it will be noted it it is occurring during emergence. Absence of it will be considered as smooth emergence | at the time of extubation |
| 10195515 | Background | Valley RD, Ramza JT, Calhoun P, Freid EB, Bailey AG, Kopp VJ, Georges LS. Tracheal extubation of deeply anesthetized pediatric patients: a comparison of isoflurane and sevoflurane. Anesth Analg. 1999 Apr;88(4):742-5. doi: 10.1097/00000539-199904000-00010. |
| 8024135 | Background | Neelakanta G, Miller J. Minimum alveolar concentration of isoflurane for tracheal extubation in deeply anesthetized children. Anesthesiology. 1994 Apr;80(4):811-3. doi: 10.1097/00000542-199404000-00013. |
| 11452859 | Background | Ferber J, Juniewicz H, Glogowska E, Wronski J, Abraszko R, Mierzwa J. Tramadol for postoperative analgesia in intracranial surgery. Its effect on ICP and CPP. Neurol Neurochir Pol. 2000;34(6 Suppl):70-9. |
| 17506732 | Background | Sudheer PS, Logan SW, Terblanche C, Ateleanu B, Hall JE. Comparison of the analgesic efficacy and respiratory effects of morphine, tramadol and codeine after craniotomy. Anaesthesia. 2007 Jun;62(6):555-60. doi: 10.1111/j.1365-2044.2007.05038.x. |
| 19630495 | Background | Rahimi SY, Alleyne CH, Vernier E, Witcher MR, Vender JR. Postoperative pain management with tramadol after craniotomy: evaluation and cost analysis. J Neurosurg. 2010 Feb;112(2):268-72. doi: 10.3171/2008.9.17689. |
| 10235420 | Background | Lintz W, Beier H, Gerloff J. Bioavailability of tramadol after i.m. injection in comparison to i.v. infusion. Int J Clin Pharmacol Ther. 1999 Apr;37(4):175-83. |
| 37013278 | Derived | Salam AA, Rehman A, Shamim MS, Khan FA. Effect of tramadol on extubation response and quality of emergence following Supratentorial surgery: A randomised controlled trial. J Pak Med Assoc. 2022 Nov;72(11):2160-2165. doi: 10.47391/JPMA.4082. |
0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure |
|
|
| Primary | Haemodynamic Parameters at the Time of Emergence and Postextubation | Heart rate will be recorded at 1 minute before giving the reversal (glycopyrolate and neostigmine) and then 1,2,5,10,20,30 minutes ,1,2,4 and 6 hours after extubation. If haemodynamic values of heart rate rise more than 20% from baseline values injection Metoprolol 1mg (beta blocker) bolus will be used and titrated according to response. The study will end at 6 hours post extubation. | Posted | Mean | Standard Deviation | bpm | HR from the time of extubation till 6 hours post operatively |
|
|
|
| Primary | Haemodynamic Parameters at the Time of Emergence and Postextubation | Diastolic blood pressure will be recorded at 1 minute before giving the reversal (glycopyrolate and neostigmine) and then 1,2,5,10,20,30 minutes ,1,2,4 and 6 hours after extubation. If values of blood pressure rise more than 20% from baseline values injection Metoprolol 1mg (beta blocker) bolus will be used and titrated according to response. The study will end at 6 hours post extubation. | Posted | Mean | Standard Deviation | mm Hg | Diastolic BP from the time of extubation till 6 hours post operatively |
|
|
|
| Secondary | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | Cough will be described on following scale 5 = No coughing or straining, 4 = Very smooth minimal coughing, 3 = Moderate coughing, 2 = Marked coughing or straining, 1 = Poor extubation Cough will be recorded on the above mentioned scale by resident/consultant at following time intervals of emergence
| Posted | Count of Participants | Participants | Cough at the time of emergence |
|
|
|
| Secondary | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Laryngospasm and Bronchospasm. | If there is any episode of bronchospasm or laryngospasm, it will be noted if it occured during emergence and for 6 hours post operatively. Absence of it will be considered as smooth emergence | Laryngospasm and Bronchospasm and breath holding did not occur, therefore not shown there. | Posted | Number | Number of Patients | at the time of extubation till 6 hours postoperatively |
|
|
|
| Secondary | Measure the Quality of Emergence From General Anaesthesia by Measuring Sedation Score | If there is any episode of sedation it will be noted if it occurs during emergence and for 6 hours post operatively. Absence of it will be considered as smooth emergence. sedation score will be used as 0= no sedation, 1= mildly sedated (eye opening on verbal commands), 2= moderately sedated ( awakens on giving pain), 3= deeply sedated ( not waking up even on pain) | The data was inconsistent and was not reported adequately in the questionnaire. | Posted | at the time of extubation till 6 hours postoperatively |
|
|
| Secondary | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring PONV | Post operative nausea vomiting will be recorded at RR, 2, 4 and 6 hours postoperatively. If there is any episode of PONV it will be noted. Absence of it will be considered as smooth emergence | Posted | Count of Participants | Participants | at Recovery Room , 2, 4 and 6 hours postoperatively |
|
|
|
| Secondary | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring Convulsions | Convulsions will be recorded at Recovery Room, 2, 4 and 6 hours postoperatively.If there is any episode of convulsion, it will be noted. Absence of it will be considered as smooth emergence. | Posted | Count of Participants | Participants | at Recovery Room, 2, 4 and 6 hours postoperatively |
|
|
|
| Secondary | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS | Post operative Glasgow Coma Scale (GCS) will be recorded at Recovery Room, 2, 4 and 6 hours postoperatively. If there is any deterioration in GCS less than 8/15, Patients will be intubated. GCS categories <8 Low GCS 9-12 Intermediate GCS 13-15 Full GCS | Posted | Number | Number of Patients | at Recovery Room, 2, 4 and 6 hours postoperatively |
|
|
|
| Secondary | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Mointoring Requirement of Analgesia | Requirement of analgesia will be recorded at recovery room, 2, 4 and 6 hours postoperatively. If there is any need of analgesic, it will be noted and will be considered as one of the determinants of poor quality of emergence. | Posted | Count of Participants | Participants | At Recovery room, 2, 4 and 6 hours postoperatively |
|
|
|
| Secondary | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Episodes of Denaturation | If there is any episodes of denaturation (Oxygen saturation <92%), it will be noted it it is occurring during emergence. Absence of it will be considered as smooth emergence | Posted | Count of Participants | Participants | at the time of extubation |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | Placebo | 0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure | 0 | 41 | 1 | 41 | 0 | 41 |
|
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| 1min After Extubation |
|
| 2 min |
|
| 5min |
|
| 10min |
|
| 20min |
|
| 30min |
|
| 1h |
|
| 2h |
|
| 4h |
|
| 6h |
|
| 1min After Extubation |
|
| 2 min |
|
| 5min |
|
| 10min |
|
| 20min |
|
| 30min |
|
| 1h |
|
| 2h |
|
| 4h |
|
| 6h |
|
| Moderate coughing |
|
| Very smooth minimal coughing |
|
| No coughing or straining |
|
| Ability to respond to verbal commands |
|
| At cuff deflation |
|
| At extubation |
|
| 2 minutes after extubation |
|
| 4h |
|
| 6h |
|
| 4h |
|
| 6h |
|
| Recovery Room : 13-15 |
|
| 2h : <8 |
|
| 2h : 9-12 |
|
| 2h : 13-15 |
|
| 4h : <8 |
|
| 4h : 9-12 |
|
| 4h : 13-15 |
|
| 6h : <8 |
|
| 6h : 9-12 |
|
| 6h : 13-15 |
|
| 4h |
|
| 6h |
|
| at the time of cuff deflation |
|
| at the time of extubation |
|
| 2 min after extubation |
|