Clinical trial NCT02964416: Single Dose Tramadol Effect on Extubation Response and Quality of Emergence Post-supratentorial Intracranial Surgery
Official title: Effect of Single Dose of Tramadol on Extubation Response and Quality of Emergence(Cough and Nausea Vomiting) Following Supratentorial Intracranial Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Brain Neoplasm
Keywords: supratentorial craniotomy
extubation response
emergence
tramadol
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2016-11-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility 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)

Primary outcomes:
measure: Haemodynamic Parameters at the Time of Emergence and Postextubation
timeFrame: Systolic BP from the time of extubation till 6 hours post operatively
measure: Haemodynamic Parameters at the Time of Emergence and Postextubation
timeFrame: HR from the time of extubation till 6 hours post operatively
measure: Haemodynamic Parameters at the Time of Emergence and Postextubation
timeFrame: Diastolic BP from the time of extubation till 6 hours post operatively
Secondary outcomes:
measure: Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale.
timeFrame: Cough at the time of emergence
measure: Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Laryngospasm and Bronchospasm.
timeFrame: at the time of extubation till 6 hours postoperatively
measure: Measure the Quality of Emergence From General Anaesthesia by Measuring Sedation Score
timeFrame: at the time of extubation till 6 hours postoperatively
measure: Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring PONV
timeFrame: at Recovery Room , 2, 4 and 6 hours postoperatively
measure: Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring Convulsions
timeFrame: at Recovery Room, 2, 4 and 6 hours postoperatively
measure: Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS
timeFrame: at Recovery Room, 2, 4 and 6 hours postoperatively
measure: Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Mointoring Requirement of Analgesia
timeFrame: At Recovery room, 2, 4 and 6 hours postoperatively
measure: Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Episodes of Denaturation
timeFrame: at the time of extubation
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University
state: Sindh
Study officials:
affiliation: Aga Khan University
name: Asma A Salam, MCPS, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
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