Intravenous dexmedetomidine and paracetamol in bupivacaine spinal anesthesia

Phase 4

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2019/04/018801
• Lead Sponsor: Department of Anaesthesia and Intensive Care

Brief Summary

This study is a prospective, double-blind, randomized, placebo controlled trial to compare the effects of intravenous dexmedetomidine and paracetamol on duration and quality of bupivacaine spinal anaesthesia in lower abdominal and pelvic surgeries. We aim to compare the effectiveness of the above drugs compared with placebo given 15 minutes before performing subarachnoid block on duration and quality of sensory block, motor block, and post operative analgesic requirement

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-04-25
• Study Start: 2019-04-26

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

• American Society of Anesthesiologists (ASA) class I or II 2.
• Age: 18 to 70 years 3.
• Measuring 150-180 cm height, with body mass index (BMI) of 18-35 kg/m2 4.
• Patients undergoing elective lower abdominal and pelvic surgeries requiring spinal anaesthesia (maximum surgery duration-2hours).

Exclusion Criteria

• All contraindications to spinal analgesia including bleeding diathesis, infection at the puncture site, spinal deformity, patient on anticoagulants, pre-existing neurological deficits in lower extremities, unwillingness to give consent.
• Sensory blockade inadequate for surgery.
• Patients on alpha-2 adrenergic receptors antagonists, calcium channel blockers, or angiotensin-converting enzyme inhibitors.
• Patients having cardiac rhythm abnormalities.
• History of alcoholism, drug abuse, and psychiatric disorders.
• Hepatic disease, renal disease, cardiopulmonary disease, hypertension, diabetes, central or peripheral nervous system disorders.
• Laparotomy, chronic abdominal pain undergoing treatment with opioid analgesic.
• Pregnant patients.
• Orthopaedic surgeries.
• Surgeries extending more than 2 hours.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To compare the effects of intravenous dexmedetomidine and paracetamol on duration and quality of bupivacaine spinal anaesthesia in lower abdominal and pelvic surgeries.	Intra-operatively - | 1. Time of T10 sensory block | 2. Maximal sensory block achieved | 3. Time of Bromage 3 motor block | Post-operatively - | 1. Time to sensory regression (2 dermatomes) | 2. Time to motor regression | (Bromage 1) | 3. Time of first analgesic dose (VAS 3)

Secondary Outcome Measures

Name	Time	Method
To assess the sedation score and adverse effects	1. Sedation assessed by Modified Ramsay sedation scale.

Trial Locations

Locations (1)

Government Medical College and Hospital; 🇮🇳 Chandigarh, CHANDIGARH, India

Government Medical College and Hospital

🇮🇳Chandigarh, CHANDIGARH, India

Dr Sarabjeet Chhabra

Principal investigator

9805917372

drsarabjeetchhabra@hotmail.com