Effect of adding midazolam to bupivacaine during spinal anaesthesia

Completed

• Conditions: ASA I and II patients posted for elective infra umbilical surgery

• Registration Number: CTRI/2013/04/003600
• Lead Sponsor: Institute of Post Graduate Medical Education and Reseach Kolkata

Brief Summary

Background:Spinal anesthetic technique is one of the common procedures used for variousinfra umbilical surgeries. Duration of post operative analgesia is one of theimportant concerns while  performing thisprocedure. Several adjuvants have been tried along with local anesthetic forprolonging the duration of analgesia. In this study we have observed the effectof midazolam as an adjuvant in patients undergoing infra umbilical surgery.

Settingsand Design: A prospective, randomized, double blinded, parallel group, placebocontrolled, open label study tertiary care hospital.

Methods:90 adult patients aged 18 – 60 years, of American Society of Anaesthesiologists(ASA) status I and II, scheduled for elective infraumbilical surgery, were randomlyallocated in two groups. Each patient in group “B†received bupivacaine 12.5mg along with 0.4 ml of normal salinein the subarachnoid block, and patients of group “BM†received 12.5 mgbupivacaine along with preservative free midazolam 0.4ml (2mg). Duration ofanalgesia was calculated from time of administration of the block torequirement of rescue analgesic as demanded by the patient in the postoperative period.

Statisticalanalysis: SPSS v17.0 was used for analysis of data. A p-value < 0.05 wasconsidered statistically significant.

Results& conclusion: Use of midazolam as adjuvant with the local anestheticsignificantly increases the duration of analgesia and motor block but a lessPONV.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-06
• Last Update Posted: 2013-04-24

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

adult patients of ASA physical status I and II and aged 18 – 60 years undergoing elective infra-umbilical (gynaecologic/urologic) under spinal subarachnoid block anesthesia were included into the study.

Exclusion Criteria

Patients refusing to participate, Patients with known allergic to local anaesthetic and midazolam, Patients suffering from chronic pain, and pregnant women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of analgesia	time from administration of block to demand of first rescue analgesia in post operative period

Secondary Outcome Measures

Name	Time	Method
Duration of motor block	Hemodynamic changes

Trial Locations

Locations (1)

IPGME&R and SSKM Hospital, Kolkata; 🇮🇳 Kolkata, WEST BENGAL, India

IPGME&R and SSKM Hospital, Kolkata

🇮🇳Kolkata, WEST BENGAL, India

Dr Anirban Chattopadhyay

Principal investigator

09867198844

smaitra.ipgmer@gmail.com