Effect of administration of the sedative drug, dexmedetomidine, on the pattern of recovery, in patients undergoing neurosurgery under general anesthesia

Phase 4

Not yet recruiting

Conditions: Malignant neoplasm of brain, unspecified, (2) ICD-10 Condition: D332||Benign neoplasm of brain, unspecified,

Registration Number: CTRI/2019/01/017108

Lead Sponsor: Dr Unnikrishnan P

Brief Summary: This is a prospective, randomized, double blinded, single center, case control study, comparing the recovery profile of 4 groups of patients (each consisting of 20) receiving anesthesia using any among Sevoflurane or Sevoflurane + Dexmedetomidine or Isoflurane or Isoflurane + Dexmedetomidine, based on time taken to attain various clinical endpoints during recovery and also by assessing the Richmond Agitation-Sedation Scale and Visual Analogue Scale scores at extubation, at 30 minutes, at 60 minutes, at 90 minutes and at 120 minutes after extubation (Primary outcome measure). As a secondary outcome measure, we will also be comparing the hemodynamic parameters in each group during the intraoperative period and also will be looking for the presence of any pain, nausea or vomiting during the first 2 hours following extubation.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

Patients categorized as American society of Anesthesiology (ASA) class 1 and 2.
Age 18-40 years.
Glasgow coma scale 15.
Patients undergoing surgeries with predicted duration >4 hours, for supratentorial lesions.

Exclusion Criteria

Patient refusal American society of Anesthesiology (ASA) class III and above Age less than 18 years and more than 40 years Emergency surgery Presence of intracranial vascular abnormalities ( Aneurysm, Arterio venous malformation) Known allergy to Dexmedetomidine or any Î±2 agonists Preoperative heart rate <50 bpm, Presence of Heart block Antihypertensive medication with Î±-methyldopa or Clonidine Patient on beta blockers Presence of Coronary artery disease, Left ventricular dysfunction Pregnant or Nursing woman Participation in another drug study during the preceding 1 month period.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the recovery profile of patients receiving low dose dexmedetomidine along with volatile anesthetics	Time taken (1) to open eyes (2) to obey verbal commands (3) to pass extubation criteria and (4) to get oriented to place and time once maintenance anesthetics are discontinued; RASS and VAS scores at extubation, 30, 60, 90 and 120 minutes after extubation

Secondary Outcome Measures

Name	Time	Method
Hemodynamic parameters during the intraoperative period	Every 10 minutes starting from induction; continued till the patient is shifted out of OR
Any pain, nausea or vomiting in the post extubation period	Observed for the first 2 hours after extubation

Trial Locations

Locations (1): Sree Chitra Tirunal Institute for Medical Sciences and Technology
🇮🇳
Thiruvananthapuram, KERALA, India
Sree Chitra Tirunal Institute for Medical Sciences and Technology
🇮🇳Thiruvananthapuram, KERALA, India
Unnikrishnan P
Principal investigator
9447662321
drunnikrishnanp@gmail.com