A study to compare decrease in stress response during skull pin insertion between intravenous dexmedetomidine and local infiltration of ropivacaine.

Completed

• Conditions: Other specified disorders of brain, Patients of 18-65 years ASA grade 1 to 3 scheduled to undergo elective craniotomy under general anaesthesia requiring application of head- holder.,

• Registration Number: CTRI/2019/02/017784
• Lead Sponsor: Department of anaesthesiology

Brief Summary

The present prospective , randomized, comparative, double blind study will be conducted in the Department of Anaesthesiology and Critical Care, PGIMS, rohtak. Written informed and witnessed consent taken for participation. 18-65 years of patients of either sex belonging to ASA grade 2 or 3 undergoing elective craniotomy will be included. The patients will be divided in two groups one will receive intravenous dexmedetomidine other will recei8ve local infiltration of ropivacaine during skullpin insertion. Vitals and other parameters will be recorded at specified time interval.

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-05-24
• Last Update Posted: 2019-06-28
• Study Start: 2019-08-03

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

ASA grade 1 to 3 undergoing elective craniotomy under general anaesthesia requiring application of head holder.

Exclusion Criteria

bradycardia(<50) second or third degree heart block uncontrolled hypertention cardiac, renal or hepatic disease history of beta blocker intake glasgow coma scale <13 pitutary disease known allergic to local anaesthetic or dexmedetomidine.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of efficacy of intravenous dexmedetomidine in decreasing skull pin insertion response i.e. alteration in heart rate, mean arterial pressure, BIS, perfusion index,serum cortisol, serum prolactin& blood glucose.	Vitals are recorded at baseline, after induction, after intubation, 1, 3, 5 minutes after intubation, before and after study drug , before and after skullpin insertion, 1, 3, 5, 10, 15, 20 minutes after skullpin insertion . serum cortisol ,prolactin and blood sugar are measured baseline and 30 minutes after skullpin insertion.

Secondary Outcome Measures

Name	Time	Method
systolic blood pressure, diastolic blood pressure, end tidal carbon dioxide level, SpO2, Fiso will be noted	Recorded at baseline, after induction, after intubation, 1, 3, 5 minutes after intubation, before and after study drug , before and after skullpin insertion, 1, 3, 5, 10, 15, 20 minutes after skullpin insertion

Trial Locations

Locations (1)

PT B D Sharma PGIMS rohtak; 🇮🇳 Rohtak, HARYANA, India

PT B D Sharma PGIMS rohtak

🇮🇳Rohtak, HARYANA, India

Dr Renu Bala

Principal investigator

9416488627

neurodmrenu@yahoo.com