Trial Outcomes & Findings for Single Dose Tramadol Effect on Extubation Response and Quality of Emergence Post-supratentorial Intracranial Surgery (NCT NCT02964416)

Last Updated: 2020-08-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

80 participants

Primary outcome timeframe

Systolic BP from the time of extubation till 6 hours post operatively

Results posted on

2020-08-04

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	39	41
Overall Study COMPLETED	38	41
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Single Dose Tramadol Effect on Extubation Response and Quality of Emergence Post-supratentorial Intracranial Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tramadol n=38 Participants 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 n=41 Participants 0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure	Total n=79 Participants Total of all reporting groups
Age, Continuous	43.42 Years STANDARD_DEVIATION 13.2 • n=5 Participants	45.9 Years STANDARD_DEVIATION 15.9 • n=7 Participants	44.7 Years STANDARD_DEVIATION 14.6 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	28 Participants n=7 Participants	55 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	38 Participants n=5 Participants	41 Participants n=7 Participants	79 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	00 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Pakistan	38 participants n=5 Participants	41 participants n=7 Participants	79 participants n=5 Participants
BMI	26.2 kg/m2 STANDARD_DEVIATION 4.80 • n=5 Participants	27.1 kg/m2 STANDARD_DEVIATION 4.88 • n=7 Participants	26.7 kg/m2 STANDARD_DEVIATION 4.83 • n=5 Participants

PRIMARY outcome

Timeframe: Systolic BP from the time of extubation till 6 hours post operatively

Outcome measures

Outcome measures
Measure	Tramadol n=38 Participants 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 n=41 Participants 0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure
Haemodynamic Parameters at the Time of Emergence and Postextubation 2h	127.76 mm Hg Standard Deviation 16.21	125.74 mm Hg Standard Deviation 13.30
Haemodynamic Parameters at the Time of Emergence and Postextubation 4h	127.35 mm Hg Standard Deviation 15.48	125.81 mm Hg Standard Deviation 12.58
Haemodynamic Parameters at the Time of Emergence and Postextubation Baseline	128.55 mm Hg Standard Deviation 21.56	132.34 mm Hg Standard Deviation 22.38
Haemodynamic Parameters at the Time of Emergence and Postextubation 1min Before Extubation	132.63 mm Hg Standard Deviation 22.12	134.29 mm Hg Standard Deviation 24.40
Haemodynamic Parameters at the Time of Emergence and Postextubation 1min After Extubation	141.81 mm Hg Standard Deviation 23.15	143.70 mm Hg Standard Deviation 22.97
Haemodynamic Parameters at the Time of Emergence and Postextubation 2 min	134.89 mm Hg Standard Deviation 21.57	139.77 mm Hg Standard Deviation 22.28
Haemodynamic Parameters at the Time of Emergence and Postextubation 5min	130.05 mm Hg Standard Deviation 20.06	133.37 mm Hg Standard Deviation 21.08
Haemodynamic Parameters at the Time of Emergence and Postextubation 10min	126.95 mm Hg Standard Deviation 17.26	131.59 mm Hg Standard Deviation 17.35
Haemodynamic Parameters at the Time of Emergence and Postextubation 20min	127.86 mm Hg Standard Deviation 14.56	133.15 mm Hg Standard Deviation 15.68
Haemodynamic Parameters at the Time of Emergence and Postextubation 30min	127.19 mm Hg Standard Deviation 16.29	132.10 mm Hg Standard Deviation 17.05
Haemodynamic Parameters at the Time of Emergence and Postextubation 1h	128.11 mm Hg Standard Deviation 14.47	129.80 mm Hg Standard Deviation 16.51
Haemodynamic Parameters at the Time of Emergence and Postextubation 6h	122.97 mm Hg Standard Deviation 14.18	122.61 mm Hg Standard Deviation 17.79

PRIMARY outcome

Timeframe: HR from the time of extubation till 6 hours post operatively

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.

Outcome measures

Outcome measures
Measure	Tramadol n=38 Participants 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 n=41 Participants 0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure
Haemodynamic Parameters at the Time of Emergence and Postextubation Baseline	82.26 bpm Standard Deviation 12.77	79.37 bpm Standard Deviation 16.93
Haemodynamic Parameters at the Time of Emergence and Postextubation 1min Before Extubation	89.30 bpm Standard Deviation 14.50	91.41 bpm Standard Deviation 16.96
Haemodynamic Parameters at the Time of Emergence and Postextubation 1min After Extubation	93.61 bpm Standard Deviation 15.39	98.54 bpm Standard Deviation 19.81
Haemodynamic Parameters at the Time of Emergence and Postextubation 2 min	89.61 bpm Standard Deviation 16.71	93.50 bpm Standard Deviation 17.46
Haemodynamic Parameters at the Time of Emergence and Postextubation 5min	86.27 bpm Standard Deviation 15.77	90.00 bpm Standard Deviation 17.40
Haemodynamic Parameters at the Time of Emergence and Postextubation 10min	86.26 bpm Standard Deviation 16.59	86.70 bpm Standard Deviation 16.76
Haemodynamic Parameters at the Time of Emergence and Postextubation 20min	82.44 bpm Standard Deviation 16.18	83.38 bpm Standard Deviation 15.20
Haemodynamic Parameters at the Time of Emergence and Postextubation 30min	81.92 bpm Standard Deviation 14.19	84.10 bpm Standard Deviation 14.95
Haemodynamic Parameters at the Time of Emergence and Postextubation 1h	79.53 bpm Standard Deviation 13.34	82.46 bpm Standard Deviation 13.52
Haemodynamic Parameters at the Time of Emergence and Postextubation 2h	80.03 bpm Standard Deviation 13.40	81.97 bpm Standard Deviation 14.90
Haemodynamic Parameters at the Time of Emergence and Postextubation 4h	78.94 bpm Standard Deviation 13.20	81.23 bpm Standard Deviation 16.58
Haemodynamic Parameters at the Time of Emergence and Postextubation 6h	79.65 bpm Standard Deviation 11.78	78.20 bpm Standard Deviation 15.94

PRIMARY outcome

Timeframe: Diastolic BP from the time of extubation till 6 hours post operatively

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.

Outcome measures

Outcome measures
Measure	Tramadol n=38 Participants 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 n=41 Participants 0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure
Haemodynamic Parameters at the Time of Emergence and Postextubation 1min After Extubation	83.97 mm Hg Standard Deviation 10.69	85.78 mm Hg Standard Deviation 13.59
Haemodynamic Parameters at the Time of Emergence and Postextubation Base line	75.92 mm Hg Standard Deviation 11.48	77.83 mm Hg Standard Deviation 12.93
Haemodynamic Parameters at the Time of Emergence and Postextubation 1min Before Extubation	77.30 mm Hg Standard Deviation 11.96	78.65 mm Hg Standard Deviation 12.63
Haemodynamic Parameters at the Time of Emergence and Postextubation 2 min	79.19 mm Hg Standard Deviation 10.79	82.41 mm Hg Standard Deviation 12.32
Haemodynamic Parameters at the Time of Emergence and Postextubation 5min	78.68 mm Hg Standard Deviation 10.63	78.59 mm Hg Standard Deviation 10.09
Haemodynamic Parameters at the Time of Emergence and Postextubation 10min	77.37 mm Hg Standard Deviation 10.26	78.32 mm Hg Standard Deviation 8.43
Haemodynamic Parameters at the Time of Emergence and Postextubation 20min	78.19 mm Hg Standard Deviation 9.54	76.73 mm Hg Standard Deviation 9.77
Haemodynamic Parameters at the Time of Emergence and Postextubation 30min	77.14 mm Hg Standard Deviation 9.67	76.93 mm Hg Standard Deviation 9.37
Haemodynamic Parameters at the Time of Emergence and Postextubation 1h	76.39 mm Hg Standard Deviation 8.90	75.33 mm Hg Standard Deviation 8.64
Haemodynamic Parameters at the Time of Emergence and Postextubation 2h	75.71 mm Hg Standard Deviation 11.07	75.89 mm Hg Standard Deviation 8.87
Haemodynamic Parameters at the Time of Emergence and Postextubation 4h	74.85 mm Hg Standard Deviation 9.96	78.00 mm Hg Standard Deviation 11.96
Haemodynamic Parameters at the Time of Emergence and Postextubation 6h	75.26 mm Hg Standard Deviation 12.54	74.89 mm Hg Standard Deviation 11.72

SECONDARY outcome

Timeframe: Cough at the time of emergence

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 * At resumption of spontaneous breathing, * Ability to respond to verbal commands * At cuff deflation * At extubation * 2 minutes after extubation. It will be noted if it occurs during emergence at the above mentioned time intervals. Absence of it will be considered as smooth emergence.

Outcome measures

Outcome measures
Measure	Tramadol n=38 Participants 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 n=41 Participants 0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. At extubation · Marked coughing or straining	0 Participants	1 Participants
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. At extubation · Moderate coughing	2 Participants	2 Participants
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. At extubation · Very smooth minimal coughing	4 Participants	6 Participants
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. At extubation · No coughing or straining	32 Participants	32 Participants
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. At resumption of spontaneous breathing · Poor extubation	0 Participants	0 Participants
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. At resumption of spontaneous breathing · Marked coughing or straining	2 Participants	2 Participants
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. At resumption of spontaneous breathing · Moderate coughing	1 Participants	1 Participants
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. At resumption of spontaneous breathing · Very smooth minimal coughing	2 Participants	2 Participants
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. At resumption of spontaneous breathing · No coughing or straining	33 Participants	36 Participants
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. Ability to respond to verbal commands · Poor extubation	0 Participants	0 Participants
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. Ability to respond to verbal commands · Marked coughing or straining	0 Participants	1 Participants
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. Ability to respond to verbal commands · Moderate coughing	1 Participants	1 Participants
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. Ability to respond to verbal commands · Very smooth minimal coughing	3 Participants	2 Participants
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. Ability to respond to verbal commands · No coughing or straining	34 Participants	37 Participants
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. At cuff deflation · Poor extubation	0 Participants	0 Participants
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. At cuff deflation · Marked coughing or straining	0 Participants	1 Participants
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. At cuff deflation · Moderate coughing	3 Participants	3 Participants
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. At cuff deflation · Very smooth minimal coughing	1 Participants	4 Participants
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. At cuff deflation · No coughing or straining	34 Participants	33 Participants
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. At extubation · Poor extubation	0 Participants	0 Participants
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. 2 minutes after extubation · Poor extubation	0 Participants	0 Participants
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. 2 minutes after extubation · Marked coughing or straining	2 Participants	0 Participants
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. 2 minutes after extubation · Moderate coughing	0 Participants	2 Participants
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. 2 minutes after extubation · Very smooth minimal coughing	0 Participants	2 Participants
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. 2 minutes after extubation · No coughing or straining	36 Participants	37 Participants

SECONDARY outcome

Timeframe: at the time of extubation till 6 hours postoperatively

Population: Laryngospasm and Bronchospasm and breath holding did not occur, therefore not shown there.

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

Outcome measures

Outcome measures
Measure	Tramadol n=38 Participants 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 n=41 Participants 0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Laryngospasm and Bronchospasm.	0 Number of Patients	0 Number of Patients

SECONDARY outcome

Timeframe: at the time of extubation till 6 hours postoperatively

Population: The data was inconsistent and was not reported adequately in the questionnaire.

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)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at Recovery Room , 2, 4 and 6 hours postoperatively

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

Outcome measures

Outcome measures
Measure	Tramadol n=38 Participants 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 n=41 Participants 0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure
Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring PONV Recovery Room	0 Participants	0 Participants
Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring PONV 2h	3 Participants	3 Participants
Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring PONV 4h	0 Participants	1 Participants
Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring PONV 6h	0 Participants	1 Participants

SECONDARY outcome

Timeframe: at Recovery Room, 2, 4 and 6 hours postoperatively

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.

Outcome measures

Outcome measures
Measure	Tramadol n=38 Participants 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 n=41 Participants 0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure
Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring Convulsions Recovery Room	0 Participants	0 Participants
Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring Convulsions 2h	0 Participants	0 Participants
Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring Convulsions 4h	1 Participants	0 Participants
Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring Convulsions 6h	0 Participants	0 Participants

SECONDARY outcome

Timeframe: at Recovery Room, 2, 4 and 6 hours postoperatively

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

Outcome measures

Outcome measures
Measure	Tramadol n=38 Participants 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 n=41 Participants 0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure
Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS Recovery Room : <8	0 Number of Patients	0 Number of Patients
Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS Recovery Room : 9-12	1 Number of Patients	0 Number of Patients
Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS Recovery Room : 13-15	38 Number of Patients	41 Number of Patients
Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS 2h : <8	0 Number of Patients	0 Number of Patients
Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS 2h : 9-12	1 Number of Patients	1 Number of Patients
Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS 2h : 13-15	38 Number of Patients	40 Number of Patients
Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS 4h : <8	0 Number of Patients	1 Number of Patients
Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS 4h : 9-12	0 Number of Patients	0 Number of Patients
Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS 4h : 13-15	39 Number of Patients	40 Number of Patients
Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS 6h : <8	0 Number of Patients	1 Number of Patients
Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS 6h : 9-12	0 Number of Patients	0 Number of Patients
Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS 6h : 13-15	39 Number of Patients	40 Number of Patients

SECONDARY outcome

Timeframe: At Recovery room, 2, 4 and 6 hours postoperatively

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.

Outcome measures

Outcome measures
Measure	Tramadol n=38 Participants 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 n=41 Participants 0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure
Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Mointoring Requirement of Analgesia Recovery Room	5 Participants	3 Participants
Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Mointoring Requirement of Analgesia 2h	15 Participants	23 Participants
Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Mointoring Requirement of Analgesia 4h	3 Participants	4 Participants
Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Mointoring Requirement of Analgesia 6h	6 Participants	7 Participants

SECONDARY outcome

Timeframe: at the time of extubation

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

Outcome measures

Outcome measures
Measure	Tramadol n=38 Participants 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 n=41 Participants 0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Episodes of Denaturation at resumption of spontaneous breathing	0 Participants	0 Participants
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Episodes of Denaturation at the time of obeying of verbal commands	0 Participants	0 Participants
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Episodes of Denaturation at the time of cuff deflation	0 Participants	0 Participants
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Episodes of Denaturation at the time of extubation	0 Participants	0 Participants
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Episodes of Denaturation 2 min after extubation	0 Participants	0 Participants

Adverse Events

Tramadol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tramadol n=38 participants at risk Injection Tramadol 100mg diluted in 10 cc syringe (10mg/ml) to be given as 1mg/kg once at the time of dura closure	Placebo n=41 participants at risk 0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure
Endocrine disorders low conscious levels in post operative period	0.00% 0/38 • 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.	2.4% 1/41 • Number of events 1 • 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.

Other adverse events

Adverse event data not reported

Additional Information

Dr Asma Abdus Salam

Aga Khan University

Phone: +92-21-34864715

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place