Phase 4 N=80 Randomized Quadruple-blind Prevention

Single Dose Tramadol Effect on Extubation Response and Quality of Emergence Post-supratentorial Intracranial Surgery

Brain Neoplasm

Bottom Line

View on ClinicalTrials.gov: NCT02964416 ↗

Enrolled (actual)

Serious AEs

1.3%

Results posted

Aug 2020

Primary outcome: Primary: Haemodynamic Parameters at the Time of Emergence and Postextubation — 128.55; 132.34; 132.63; 134.29 mm Hg

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Injection Tramadol (Drug); placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Aga Khan University
Primary completion: Mar 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Haemodynamic Parameters at the Time of Emergence and Postextubation	75.92; 77.83; 77.30; 78.65; 83.97; 85.78	—
PRIMARY Haemodynamic Parameters at the Time of Emergence and Postextubation	75.92; 77.83; 77.30; 78.65; 83.97; 85.78	—
PRIMARY Haemodynamic Parameters at the Time of Emergence and Postextubation	75.92; 77.83; 77.30; 78.65; 83.97; 85.78	—
SECONDARY Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale.	0; 0; 2; 2; 1; 1	—
SECONDARY Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Laryngospasm and Bronchospasm.	0; 0	—
SECONDARY Measure the Quality of Emergence From General Anaesthesia by Measuring Sedation Score	—	—
SECONDARY Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring PONV	0; 0; 3; 3; 0; 1	—
SECONDARY Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring Convulsions	0; 0; 0; 0; 1; 0	—
SECONDARY Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS	0; 0; 1; 0; 38; 41	—
SECONDARY Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Mointoring Requirement of Analgesia	5; 3; 15; 23; 3; 4	—
SECONDARY Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Episodes of Denaturation	0; 0; 0; 0; 0; 0	—

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.

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02964416). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.