Dosage for dexmedetomidine in spinal anaesthesia

Not yet recruiting

Conditions: Medical and Surgical, (2) ICD-10 Condition: 8||Other Procedures,

Registration Number: CTRI/2021/07/034532

Lead Sponsor: Shri Ram Murti Smarak Institute of Medical Sciences

Brief Summary: **BACKGROUND:** Dexmedetomidine is increasingly being used in regional anesthesia as an adjuvant but there is no consensus on the optimum dose when used intrathecally. The study will be conducted to elucidate the dose-response relation between 3 different doses (2.5, 5, and 10 mcg) of Intrathecal dexmedetomidine as an adjuvant to hyperbaric 0.5% bupivacaine in patients undergoing elective lower abdominal and lower limb surgeries.

**METHODS**: 90 Patients (18-60 years) will be randomized into 3 groups of 30 patients each to receive Intrathecal bupivacaine 12.5 mg (2.5 ml) with 2.5 mcg (group A), 5ug (group B), 10ug (group C) dexmedetomidine, respectively. Duration of the spinal sensory blockade (primary outcome), the onset of the blockade, time to rescue analgesia, level of sedation, duration of motor blockade, comparison of hemodynamic variables, and complications, if any, will be assessed.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 90

Inclusion Criteria

Ninety patients belonging to ASA physical status I/II, aged 18-60 years of either sex, undergoing elective lower abdominal and lower limb surgeries under planned Subarachnoid Block (SAB).

Exclusion Criteria

Exclusion criteria included patient refusal, contraindication to SAB, hypersensitivity to the drugs being evaluated, Body Mass Index (BMI) more than 40 kg/m2, pregnancy, significant comorbid conditions like uncontrolled hypertension, congestive heart failure, myocardial infarction in the past 6 months, heart block, fixed cardiac output lesions.
Cases that needed intraoperative conversion to general anesthesia were also excluded.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective was to ascertain a safe IT dexmedetomidine dose for patients undergoing elective lower abdominal and lower limb surgeries and to analyze sensory and motor characteristics with drug combinations being evaluated by comparing duration of the spinal sensory blockade, onset of the sensory and motor blockade	Onset of sensory blockade shall be defined as the time taken from the drug injection to the time to reach T10 level and the offset of sensory block shall be presumed when pin prick sensation at S1 dermatome has returned. Duration of sensory block will be defined as the time interval elapsed between onset of sensory block at T10 to regression of sensory block to S1.

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measures included level of sedation, comparison of hemodynamic variables and complications, if any.	HR, NIBP(systolic , diastolic and mean NIBP) ,SpO2 will be monitored continuously during the course of surgery and data will be recorded at 5 minutes interval for first 20 minutes then at 15 minutes interval till end of first hour, then at 30 minutes interval for next one hour, hourly for further 2 hours, followed by 4 hourly till completion of 24 hrs

Trial Locations

Locations (1): Department of Anaesthesia, OT complex,first floor, SRMSIMS
🇮🇳
Bareilly, UTTAR PRADESH, India
Department of Anaesthesia, OT complex,first floor, SRMSIMS
🇮🇳Bareilly, UTTAR PRADESH, India
Dr Ashita Mowar Pahade
Principal investigator
9568578724
drash.royals@gmail.com