Single Dose Tramadol Effect on Extubation Response and Quality of Emergence Post-supratentorial Intracranial Surgery
NCT ID: NCT02964416
Last Updated: 2020-08-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
80 participants
INTERVENTIONAL
2016-03-31
2018-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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
Interventions
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Injection Tramadol
placebo
0.9% Normal saline in 10 ml syringe
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* American Society of Anaesthesiologists (ASA) 2 and stable ASA 3 patients
* Elective surgery
* Patients with Glasgow Coma Scale (GCS) 15/15
Exclusion Criteria
* 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)
18 Years
65 Years
ALL
No
Sponsors
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Aga Khan University
OTHER
Responsible Party
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Asma Abdus Salam
Senior Instructor
Principal Investigators
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Asma A Salam, MCPS, FCPS
Role: PRINCIPAL_INVESTIGATOR
Aga Khan University
Locations
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Aga Khan University
Karachi, Sindh, Pakistan
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2954-Ane-ERC-14
Identifier Type: -
Identifier Source: org_study_id
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