Effect of add-on gabapentin premedication on hemodynamic response to skull pin insertion in patients undergoing craniotomy

Phase 1

• Conditions: Health Condition 1: null- Patients between 18 to 60 years, belonging to ASA Physical status I and II scheduled for elective craniotomy in supine position for intracranial tumor surgery.

• Registration Number: CTRI/2018/03/012809
• Lead Sponsor: Department of Anesthesia Dayanand Medical College and Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Patients between 18 to 60 years of age, of either sex belonging to American Society of Anaesthesiologists (ASA) Physical status I and II scheduled for elective craniotomy in supine position for intracranial tumor surgery.

Exclusion Criteria

1. Patients undergoing craniotomy for emergency surgery.

2. Patients with clinical features suggestive of raised ICP like altered sensorium, hypertension, bradycardia or pupillary dilatation.

3. Patients with known history of drug allergy to either gabapentin or lignocaine.

4. Obese patients (body mass index >30 kg m-2 for males and 28 kg m-2 for females.)

5. Patients having systemic co-morbidities (acute or chronic renal failure, Ischemic heart disease, cirrhosis of liver, uncontrolled diabetes mellitus or other endocrinopathies.)

6. Patients with uncontrolled hypertension.

7. Patients undergoing intracranial aneurysm clipping (as most of them are on antihypertensive drugs and/or nimodipine),

8. Patients with known or suspected pregnancy.

9. Patients on anti-psychotic medications.

10. Patients on gabapentin as part of antiepileptic drug therapy (patients receiving only phenytoin or only levetiracetam as monotherapy were considered for inclusion.)

11. Patients in whom the Mayfield clamp was applied more than once.

12. Patients undergoing tumor decompression in positions other than supine.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of oral gabapentin premedication with local infiltration of LA on hemodynamic response to skull pin insertionTimepoint: Heart rate,Systolic blood pressure,Diastolic blood pressure and Mean arterial pressure were recorded before induction of anesthesia(baseline),just before administration of pin site injection,one minute after skull infiltration but just before application of pin and at every 30 seconds interval after pin insertion until the end of 10 minutes

Secondary Outcome Measures

Name	Time	Method
To evaluate the efficacy of oral gabapentin premedication with local infiltration of LA on emergence time from anesthesiaTimepoint: From time of discontinuation of anesthetics to the time when patient was able to recall his/her name and date of birth(on verbal prompting every 2 min after extubation)