To compare the effects of two drugs dexmedetomidine and fentanyl when used in spinal anaesthesia.

Recruiting

• Conditions: comparing the effect of adding 2 drugs - dexmedetomidine and fentanyl on duration of spinal anaesthesia

• Registration Number: CTRI/2013/03/003451

Brief Summary

Spinal anaesthesia is very commonly used in lower abdominal and genitourethral surgeries as it is economical and easy to administer. But post operative pain relief is a major problem as local anaesthetics with short duration of action are used in spinal anaesthesia. Hence a number of adjuvants like clonidine, buprenorphine have been studied to prolong the duration of spinal anaesthesia.         The addition of fentanyl improves the quality of intraoperative and early postoperative subarachnoid block. But it has got disadvantages like nausea, vomiting, pruritus, respiratory depression etc.         Dexmedetomidine is an alpha 2 agonist which provides good quality of intraoperative and postoperative analgesia with minimal side effects. Based on earlier human studies, it is hypothesised that intrathecal 5 microgram dexmedetomidine would produce more postoperative analgesic effect with hyperbaric bupivacaine in spinal anaesthesia with minimal side effects.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-01
• Last Update Posted: 2013-02-21

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

ASA 1 & 11 patients undergoing lower abdominal and genitourethral surgeries.

Exclusion Criteria

Hypertension, cardiac diseases including conduction defects, contraindications to spinal anaesthesia, allergy to amide type of local anaesthetics or dexmedetomidine or fentanyl.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
difference between the duration of sensory blockade when dexmedetomidine and fentanyl are used as adjuvants to bupivacaine in spinal anaesthesia	5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240.

Secondary Outcome Measures

Name	Time	Method
to compare motor block characteristics, sedation score and side effect profile of the two drugs in study.	5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240

Trial Locations

Locations (1)

Department of Anaesthesia; 🇮🇳 Thiruvananthapuram, KERALA, India

Department of Anaesthesia

🇮🇳Thiruvananthapuram, KERALA, India

DR BINCY V THOMAS

Principal investigator

09496826464

bincyvthomas@yahoo.com