Fentanyl vs Dexmedetomidine with intrathecal levobupivacaine in elective cesarean section

Phase 4

Not yet recruiting

Conditions: Medical and Surgical,

Registration Number: CTRI/2021/09/036511

Lead Sponsor: MOHAMED BASITH

Brief Summary: After getting approval from the ethical committee, the patients who were willing for the study, fulfilling the criteria for the study will be included.The patients would be randomly divided into two groups by computer generated list of random numbers. Doses will be calculated after analyzing previous studies.Group 1 (LF) will receive 0.5% levobupivacaine 2ml + fentanyl 25 mcg.Group 2 (LD)will receive 0.5%levobupivacaine 2ml + dexmedetomidine 5 mcg.The patient as well as the anesthetist involved in the study will be blinded to the drug used. Separate independent anesthesiologist who otherwise will not be a part of the procedure will prepare the syringe with drugs and will hand it over to the attending anesthesiologist.On the day before the surgery patient will be assessed in the pre anaesthetic clinic. Patient will be kept NPO 8 hours before surgery. Pre medication with T.alprazolam 0.5 mg and inj.pantoprazole 40 mg IM will be given. Standared ASA monitoring like non invasive blood pressure , ECG, pulse oximetry are observed. Patients will be cannulated with 18 G intravenous cannula. Patients will be preloaded with 15 ml / kg of ringer lactate. Spinal will be given with the labeled syringe ,patient will be put in supine position and sensory level should be checked with pin prick method ,review of motor blocked is assessed with bromage scale .intraoperative parameters like BP, PR and spo2 will be recorded every 5minutes for the first 20 minutes then every 10 minutes till the end of the surgery. Pain score will be monitored by VAS score postoperatively patient will be observed for 24 hours for postoperative complications like nausea, vomiting ,pruritis, shivering, respiratory depression, hypotension, bradycardia.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 75

Inclusion Criteria

WOMEN WITH FULL TERM PREGNANCIES WOMEN BELONGING TO ASA 1 AND 2 POSTED FOR ELECTIVE CESAREAN SECTION AGE GROUP 18-35 YEARS.

Exclusion Criteria

EMERGENCY CESAREAN SECTION MATERNAL MEDICAL CO-MORBIDITIES INFECTION AT NEEDLE SITE REFUSAL TO SPINAL ANAESTHESIA ALLERGIC TO LOCAL ANAESTHETICS AND ADJUVANTS.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TO COMPARE THE DURATION OF POST OPERATIVE ANALGESIA OF LEVOBUPIVACAINE WITH FENTANYL VERSUS LEVOBUPIVACAINE WITH DEXMEDETOMIDINE	18 MONTHS

Secondary Outcome Measures

Name	Time	Method
To compare the intraoprative haemodynamic changes, level pf motor ad sensory blockade between the two groups	18 MONTHS

Trial Locations

Locations (1): SHRI SATHYA SAI MEDICAL COLLEGE AND RESEARCH INSTITUTE
🇮🇳
Kancheepuram, TAMIL NADU, India
SHRI SATHYA SAI MEDICAL COLLEGE AND RESEARCH INSTITUTE
🇮🇳Kancheepuram, TAMIL NADU, India
MOHAMED BASITH
Principal investigator
9944882312
sweetbasith@gmail.com