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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02964416
• Date of registration: 19/09/2016
• Prospective Registration: No
• Primary sponsor: Aga Khan University
• Public title: Single Dose Tramadol Effect on Extubation Response and Quality of Emergence Post-supratentorial Intracranial Surgery
• Scientific title: Effect of Single Dose of Tramadol on Extubation Response and Quality of Emergence(Cough and Nausea Vomiting) Following Supratentorial Intracranial Surgery
• Date of first enrolment: March 2016
• Target sample size: 80
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02964416
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Pakistan

Contacts

• Name: Asma A Salam, MCPS, FCPS
• Affiliation: Aga Khan University

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Brain Neoplasm

Intervention(s)

Drug: Injection Tramadol

Other: placebo

Primary Outcome(s)

Haemodynamic Parameters at the Time of Emergence and Postextubation [Time Frame: Systolic BP from the time of extubation till 6 hours post operatively]

Haemodynamic Parameters at the Time of Emergence and Postextubation [Time Frame: Diastolic BP from the time of extubation till 6 hours post operatively]

Haemodynamic Parameters at the Time of Emergence and Postextubation [Time Frame: HR from the time of extubation till 6 hours post operatively]

Secondary Outcome(s)

Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring Convulsions [Time Frame: at Recovery Room, 2, 4 and 6 hours postoperatively]

Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS [Time Frame: at Recovery Room, 2, 4 and 6 hours postoperatively]

Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring PONV [Time Frame: at Recovery Room , 2, 4 and 6 hours postoperatively]

Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Mointoring Requirement of Analgesia [Time Frame: At Recovery room, 2, 4 and 6 hours postoperatively]

Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. [Time Frame: Cough at the time of emergence]

Measure the Quality of Emergence From General Anaesthesia by Measuring Sedation Score [Time Frame: at the time of extubation till 6 hours postoperatively]

Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Episodes of Denaturation [Time Frame: at the time of extubation]

Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Laryngospasm and Bronchospasm. [Time Frame: at the time of extubation till 6 hours postoperatively]

Secondary ID(s)

2954-Ane-ERC-14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 04/08/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02964416