To compare the effect of Dexmedetomidine versus midazolam, when both are given intravenously,as supplementation to Ropivacaine SpinalAnaesthesia

Recruiting

• Conditions: Patients undergoing lower limb and lower abdominal surgeries

• Registration Number: CTRI/2014/04/004535
• Lead Sponsor: Dr T S Punia

Brief Summary

In the present clinical study, we compare the effects of intravenous dexmedetomidine with midazolam on spinal block duration, sedation and post operative analgesia. Whereas Midazolam is only a sedative, Dexmedetomidine has both analgesic and sedative properties that may prolong the duration of sensory and motor block obtained with spinal anaesthesia.60 ASA grade I & II patients scheduled for lower limb and lower abdominal surgeries in Govt. Medical college/Rajindra hospital, Patiala will be randomly allocated to three groups of 20 each. Immediately after 3ml of 0.5% ropivacaine given intrathecally,

**Group D** (n=20):        will be administered i/v dexmedetomidine (a loading dose of 1 µg/kg over 10 min and a maintenance dose of 0.5 µg/kg/hr in form of infusion)

**Group M** (n=20):       will be given midazolam (loading dose of 0.05 mg/kg followed by infusion@0.02 mg/kg/hour), and ,

**Group C** (n=20):           will receive the normal saline.

Intraoperative haemodynamic changes, onset, level & duration of sensory block, onset and duration of motor block, level of sedation, postoperative analgesia & side effects, if any will be recorded. All findings and information, including the time for the first request for postoperative analgesia and the number of patients requiring supplemental analgesia will be recorded. All results will be analysed statistically.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-09
• Last Update Posted: 2023-01-15

Recruitment & Eligibility

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

Inclusion Criteria

ASA grade I and II Patients undergoing lower limb and lower abdominal surgery Body mass index of 30 or less Normal coagulation profile.

Exclusion Criteria

Unwilling patient, history of chronic illness, spinal abnormality, local skin infection, coagulation defects, Recent MI, Allergy to the drugs being used.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time for onset of analgesia ( highest level assessed by bilateral pin prick )	Intraoperative ,Intraoperative, Postoperative, Postoperative, Intraoperative, every 5 minutes for the first 30 minutes and then every 10 minutes till the end of surgery and then at 4, 8, 12, 24 hours postoperatively, Intraoperative, Intraoperative and Postoperative
Peak sensory level reached	Intraoperative ,Intraoperative, Postoperative, Postoperative, Intraoperative, every 5 minutes for the first 30 minutes and then every 10 minutes till the end of surgery and then at 4, 8, 12, 24 hours postoperatively, Intraoperative, Intraoperative and Postoperative
Time taken for sensory block regression by 2 dermatomes, Time taken for motor block to recede to Bromage and Postoperative	Intraoperative ,Intraoperative, Postoperative, Postoperative, Intraoperative, every 5 minutes for the first 30 minutes and then every 10 minutes till the end of surgery and then at 4, 8, 12, 24 hours postoperatively, Intraoperative, Intraoperative and Postoperative
Sedation produced by the two groups,	Intraoperative ,Intraoperative, Postoperative, Postoperative, Intraoperative, every 5 minutes for the first 30 minutes and then every 10 minutes till the end of surgery and then at 4, 8, 12, 24 hours postoperatively, Intraoperative, Intraoperative and Postoperative
Haemodynamic profile of the two groups ,	Intraoperative ,Intraoperative, Postoperative, Postoperative, Intraoperative, every 5 minutes for the first 30 minutes and then every 10 minutes till the end of surgery and then at 4, 8, 12, 24 hours postoperatively, Intraoperative, Intraoperative and Postoperative
Need of additional analgesic	Intraoperative ,Intraoperative, Postoperative, Postoperative, Intraoperative, every 5 minutes for the first 30 minutes and then every 10 minutes till the end of surgery and then at 4, 8, 12, 24 hours postoperatively, Intraoperative, Intraoperative and Postoperative
, Incidence of complications including depression, nausea, vomiting, pruritus, hypotension, bradycardia, shivering between the two groups	Intraoperative ,Intraoperative, Postoperative, Postoperative, Intraoperative, every 5 minutes for the first 30 minutes and then every 10 minutes till the end of surgery and then at 4, 8, 12, 24 hours postoperatively, Intraoperative, Intraoperative and Postoperative

Secondary Outcome Measures

Name	Time	Method
Time for onset of analgesia ( highest level assessed by bilateral pin prick )	Peak sensory level reached, Time taken for motor block to recede to Bromage and Postoperative

Trial Locations

Locations (1)

Operation Theatre complex of Rajindra Hospital, Patiala; 🇮🇳 Patiala, PUNJAB, India

Operation Theatre complex of Rajindra Hospital, Patiala

🇮🇳Patiala, PUNJAB, India

Dr Divya Arora

Principal investigator

9216265088

drdivyaarora86@gmail.com