CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 80 enrolled
Drug / intervention
Injection Tramadol +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02964416
NCT02964416Phase 4Completed

Effect of Single Dose of Tramadol on Extubation Response and Quality of Emergence(Cough and Nausea Vomiting) Following Supratentorial Intracranial Surgery

Aga Khan University·interventional·Posted Nov 16, 2016·Updated Aug 4, 2020

In Brief

A Phase 4 clinical trial evaluating Injection Tramadol and placebo for Brain Neoplasm. Completed, enrolled 80 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBrain Neoplasm
CountriesPakistan
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 16, 2016
Enrollment StartMar 1, 2016
Primary CompletionMar 1, 2018
Study CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 9.6 years ago

Interventions

Injection Tramadoldrug

placeboother

0.9% Normal saline in 10 ml syringe