Evaluation of the role of Dexmedetomidine in reducing pain after surgery for brain tumors.

Phase 3

Recruiting

• Conditions: Consenting, non pregnant, non lactating adult patients coming for supratentorial craniotomy

• Registration Number: CTRI/2017/12/011024
• Lead Sponsor: Sree Chitra Tirunal Institute for Medical Sciences and Technology

Brief Summary

Primary purpose of the study is to evaluate the effect of adding Dexmedetomidine as an adjuvant to scalp block, with respect to its effect on the duration of scalp block.Dexmedetomidine as an adjuvant to scalp block will prolong the duration of scalp block, thereby increasing the duration of the block, and therefore, decreasing the requirement of analgesic use in the post operative period.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-10
• Last Update Posted: 2017-12-27

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Consenting, non pregnant, non lactating adult patients coming for supratentorial craniotomy will participate in the study.
• Minors, neonates, persons incompetent to give informed consent, prisoners, normal/healthy volunteer, student, staff of the institute are not planned to be included in the study.

Exclusion Criteria

Previous craniotomy,Hypertensive patients, Diabetics, Pre-operative GCS < 15/15, Known allergy to local anaesthetics, Pregnancy, Scalp infection, Coagulopathy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of post-operative analgesia, defined as the time when the Visual Analog Score is greater than or equal to 4 in the post operative period	Visual Analog Score to be assessed post operatively at 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours and 24 hours.

Secondary Outcome Measures

Name	Time	Method
Post operative sedation score; Ramsay Sedation Scale	Every hour for 6 hours post operatively
Intra-operative anaesthetic requirement; Number of additional doses of Fentanyl required to ensure adequate intraoperative analgesia	At the end of surgery
Post-operative analgesia	VAS score

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

Dr Ajay Prasad Hrishi P

Principal investigator

9495239765

drajay@sctimst.ac.in