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

NCT02964416 | Completed Phase 4 Results DMC

• 1 other identifier: 2954-Ane-ERC-14
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Neoplasm

Keywords

supratentorial craniotomy; extubation response; emergence; tramadol

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (8)

• Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale.

  Cough at the time of emergence

• Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Laryngospasm and Bronchospasm.

  at the time of extubation till 6 hours postoperatively

• Measure the Quality of Emergence From General Anaesthesia by Measuring Sedation Score

  at the time of extubation till 6 hours postoperatively

• Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring PONV

  at Recovery Room , 2, 4 and 6 hours postoperatively

• Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring Convulsions

  at Recovery Room, 2, 4 and 6 hours postoperatively

Study Arms (2)

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

Drug: Injection Tramadol

Placebo

PLACEBO COMPARATOR

0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure

Other: placebo

Interventions

Injection Tramadol DRUG

Also known as: Tramal

Tramadol

placebo OTHER

0.9% Normal saline in 10 ml syringe

Also known as: normal saline

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with craniotomy for supratentorial tumors under general anesthesia
• American Society of Anaesthesiologists (ASA) 2 and stable ASA 3 patients
• Elective surgery
• Patients with Glasgow Coma Scale (GCS) 15/15

You may not qualify if:

• Patients with a history of allergy or hypersensitivity to tramadol.
• History of epilepsy or convulsions due to any reason.
• Chronic usage of analgesic drugs.
• Patients using monoamine oxidase inhibitors.
• Patients with clinical signs of raised ICP.
• Obesity (women with a body mass index \>35 kg/m2 or men with a body mass index \>42 kg/m2)
• Language barrier.
• Patients taking B-blockers or Ca channel blockers.
• Patients above 65 years of age ( Physiology difference)

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (9)

• 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.

  PMID: 8638792 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.

  PMID: 22089326 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.

  PMID: 10195515 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.

  PMID: 8024135 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.

  PMID: 11452859 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.

  PMID: 17506732 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.

  PMID: 19630495 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.

  PMID: 10235420 BACKGROUND

• 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.

  PMID: 37013278 DERIVED

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Tramadol; Saline Solution

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr Asma Abdus Salam
• Organization: Aga Khan University

asma.salam.azhar@gmail.com

+92-21-34864715

Study Officials

• Asma A Salam, MCPS, FCPS

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Instructor

Study Record Dates

• First Submitted: September 19, 2016
• First Posted: November 16, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 4, 2020
• Results First Posted: August 4, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)