Single Dose Tramadol Effect on Extubation Response and Quality of Emergence Post-supratentorial I… (NCT02964416) | Clinical Trial Compass
CompletedPhase 4
Single Dose Tramadol Effect on Extubation Response and Quality of Emergence Post-supratentorial Intracranial Surgery
Pakistan80 participantsStarted 2016-03
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Haemodynamic Parameters at the Time of Emergence and Postextubation
Timeframe: Systolic BP from the time of extubation till 6 hours post operatively
2
Haemodynamic Parameters at the Time of Emergence and Postextubation
Timeframe: HR from the time of extubation till 6 hours post operatively
3
Haemodynamic Parameters at the Time of Emergence and Postextubation
Timeframe: Diastolic BP from the time of extubation till 6 hours post operatively