Efficacy of dexmedetomidine as an adjuvant to bupivacaine in spinal anesthesia for lower abdominal surgery

Phase 4

Completed

Conditions: Conditions requiring lower abdominal surgery i.e. Inguinal hernia, Open appendicectomy

Registration Number: CTRI/2011/12/002186

Lead Sponsor: Department Of Anasthesiology

Brief Summary: Dexmedetomidine is an alpha-2 adrenergic receptor agonist recently introduced in indian market.

It has been used for premedication, as an adjuvant to general anaesthesia and for sedation in the intensive care unit. The aim of the present study is to evaluate the efficacy and safety of dexmedetomedine as an adjuvant to bupivacaine in subarachanoid block.

Study will be carried out in 100 ASA physical status 1 and 2 aged 30 to 60 years going to undergo elective lower abdominal surgery. Patient will be randomly allocated in 2 groups each of 50 by distributing sealed envelopes.1st group will be given bupivacaine and 2nd group will be given bupivacaine and dexmedetomidine in subarachnoid space. Patients will be assessed for onset, peak, duration and regression of sensory and motor block produced by boath groups. Sedation, analgesia, haemodynemic variables and complications will be recorded intraoperatively. Patients will be observed for 24 hours in post operative period. Data will be expressed as mean and standard deviation or numbers and percentages as applicable. Comparison between two groups will be done using unpaired t test for quantitative data and chi sqaure test for qualitative data. p value <0.05 is considered significant.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Male

Target Recruitment: 100

Inclusion Criteria

1.Age: 30 to 60 years.
3.Patients posted for lower abdominal surgery; i.
4.Informed written consent for participation in study.
5.BMI 25 kg/m2.

Exclusion Criteria

Uncontrolled or labile hypertension.2. Contraindication to spinal anaesthesia.3. Allergy to local anaesthetic or study drug.4. Body mass index >25 kg/m2.5. Patients taking any analgesics sedative or antihypertensive drugs.6. Neurological disorders.7. Psychiatric disorders.8. Unco- operative patients.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Onset, Peak And Duration Of Sensory And Motor Block.	0 min, 1 min, 2min, 3min, 5min, 10min, 15min,20min, 30min, 45min, 60min, 75min, 90min, 105min, 120min,135min, 150min,165min, 180min, 210min, 240min, 270min, 300min, 330min, 360min(6 hours), 8 hours, 10hours, 12hours, 14hours, 16hours, 20hours and 24hours.

Secondary Outcome Measures

Name	Time	Method
Post Operative Analgesia,Sedation And Complication If Any Withon 24 Hours Of Subarachnoid Block	0 min, 1 min, 2min, 3min, 5min, 10min, 15min,20min, 30min, 45min, 60min, 75min, 90min, 105min, 120min,135min, 150min,165min, 180min, 210min, 240min, 270min, 300min, 330min, 360min(6 hours), 8 hours, 10hours, 12hours, 14hours, 16hours, 20hours and 24hours.

Trial Locations

Locations (1): Department of anaesthesiology
🇮🇳
Bhavnagar, GUJARAT, India
Department of anaesthesiology
🇮🇳Bhavnagar, GUJARAT, India
DrDevayat RMaru
Principal investigator
09909975050
devayat_maru2004@yahoo.co.in