Single Dose Tramadol Effect on Extubation Response and Quality of Emergence Post-supratentorial Intracranial Surgery
Keywords
Abstract
Description
Extubation after intracranial tumor surgery is desirable in order to make an early diagnosis of intracranial complications. Extubation however, may be associated with haemodynamic and metabolic changes e.g. agitation, increased oxygen consumption, catecholamine secretion, hypercapnia and systemic hypertension.
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.
Dates
| Last Verified: | 10/31/2016 |
| First Submitted: | 09/18/2016 |
| Estimated Enrollment Submitted: | 11/10/2016 |
| First Posted: | 11/15/2016 |
| Last Update Submitted: | 11/10/2016 |
| Last Update Posted: | 11/15/2016 |
| Actual Study Start Date: | 02/29/2016 |
| Estimated Primary Completion Date: | 02/28/2018 |
| Estimated Study Completion Date: | 11/30/2018 |
Condition or disease
Intervention/treatment
Drug: Tramadol
Other: Placebo
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: 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 | Drug: Tramadol |
| Placebo Comparator: Placebo 0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure | Other: Placebo 0.9% Normal saline in 10 ml syringe |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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) |
Outcome
Primary Outcome Measures
1. Haemodynamic parameters at the time of emergence and postextubation [from the time of extubation till 6 hours post operatively]
2. Haemodynamic parameters at the time of emergence and postextubation [from the time of extubation till 6 hours post operatively]
Secondary Outcome Measures
1. Measure the quality of emergence from general anaesthesia by measuring the frequency of cough on cough scale. [at the time of extubation]
2. 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]
3. Measure the quality of emergence from general anaesthesia by measuring the frequency of episodes of desaturation. [at the time of extubation till 6 hours postoperatively]
4. Measure the quality of emergence from general anaesthesia by measuring sedation score [at the time of extubation till 6 hours postoperatively]
5. Effect of tramadol on quality of emergence measured by extubation response through monitoring PONV [at 2, 4 and 6 hours postoperatively]
6. Effect of tramadol on quality of emergence measured by extubation response through monitoring convulsions [at 2, 4 and 6 hours postoperatively]
7. Effect of tramadol on quality of emergence measured by extubation response through monitoring GCS [at 2, 4 and 6 hours postoperatively]
8. Effect of tramadol on quality of emergence measured by extubation response through mointoring requirement of analgesia [at 2, 4 and 6 hours postoperatively]
