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

Phase 4

• Conditions: Health Condition 1: D332- Benign neoplasm of brain, unspecifiedHealth Condition 2: C719- Malignant neoplasm of brain, unspecified

• Registration Number: CTRI/2019/01/017108
• Lead Sponsor: Dr Unnikrishnan P

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: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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 α2 agonists

Preoperative heart rate <50 bpm, Presence of Heart block

Antihypertensive medication with α-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 anestheticsTimepoint: 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
Any pain, nausea or vomiting in the post extubation periodTimepoint: Observed for the first 2 hours after extubation;Hemodynamic parameters during the intraoperative periodTimepoint: Every 10 minutes starting from induction; continued till the patient is shifted out of OR