Use of low dose of Dexmedetomidine in Neurosurgical Patients for better outcomes

Phase 4

Not yet recruiting

• Conditions: Malignant neoplasm of brain, unspecified, (2) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, (3) ICD-10 Condition: C700||Malignant neoplasm of cerebral meninges,

• Registration Number: CTRI/2023/10/058666
• Lead Sponsor: Rajendra institute of medical sciences

Brief Summary

It is a triple blind RCT, of 3 groups with 30 participants in each group, it is a comparative analysis of the effects of two different infusion doses of dexmedetomidine on hemodynamic response to extubation and the quality of extubation in the neurosurgical patients. D1 group will receive drug at a dose 0.4mcg/kg/hr and D2 will receive drug at a dose rate of 0.6mcg/kg/hr and the group C. Will be the control group will receive Normal saline. 20ml of the solution will be started at the end of surgery for about 20min and the vitals and the quality of extubtion are recorded.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-10-13
• Study Start: 2023-10-21

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1.Patient giving informed and written consent 2.ASA physical class 1 and 2 3.Patient of supratentorial space occupying lesion 4.Glasgow coma scale 15/15.

Exclusion Criteria

• 1.Patient refusal, not giving consent for study.
• 2.Pregnant and lactating women.
• 3.Patients undergoing elective surgical procedures in prone position including surgery of spine.
• 4.Patient having known case of allergy to dexmedetomidine.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To observe the airway response during tracheal extubation	30 minutes after completion of surgery
To observe the hemodynamic changes during tracheal extubation following two infusion doses of dexmedetomidine.	30 minutes after completion of surgery

Secondary Outcome Measures

Name	Time	Method
1. Time to emergence & time to tracheal extubation.	2.Early post operative complications such as coughing, laryngospasm,

Trial Locations

Locations (1)

Rajendra institute of medical sciences (RIMS) Ranchi Jharkhand; 🇮🇳 Ranchi, JHARKHAND, India

Rajendra institute of medical sciences (RIMS) Ranchi Jharkhand

🇮🇳Ranchi, JHARKHAND, India

Dr Md Tausif alam

Principal investigator

7903816386

tsf14318@gmail.com