comparison between two drugs as an additive to a local anaesthesia in spinal anaesthesia for taking baby out by surgical method.

Phase 4

Not yet recruiting

• Conditions: Obstetrics,

• Registration Number: CTRI/2023/04/051598
• Lead Sponsor: Office of the Principal, Midnapore Medical College and Hospital

Brief Summary

**PROPOSEDTOPIC OF RESEARCH**:Comparison between intrathecal fentanyl and dexmedetomidine as an adjuvant tohyperbaric 0.5% levobupivacaine in subarachnoid block for caesarean section: Aprospective study.

**OBJECTIVEOF PROPOSED RESEARCH**:To compare the duration of sensory and motor block between fentanyl anddexmedetomidine when administered intrathecally as adjuvant to 0.5% hyperbaric levobupivacainein spinal anaesthesia for elective lower segment caesarean section.

**Background of present study**: In recent years levobupivacaine, the pure S(−)-enantiomer of bupivacaine, emerged as a safer alternative for regionalanesthesia than its racemic parent. Recently 0.5% hyperbaric levobupivacaine hasbeen introduced in clinical practice and widely used as a substitution of 0.5%hyperbaric bupivacaine in spinal anaesthesia.

Toprolong the duration of sensory and motor block many adjuvants have beenpreviously added to 0.5% hyperbaric bupivacaine in spinal anaesthesia. Fentanyland dexmedetomidine both have been profoundly used as adjuvant with 0.5%hyperbaric bupivacaine in cesarean section. As there is no published data onthe effect of adjuvants with hyperbaric levobupivacaine we propose to comparethe effects of fentanyl and dexmedetomidine with 0.5% hyperbariclevobupivacaine in caesarean section.

**Methodology**: After ethicalclearance and written informed consent, 105 mothers undergoing electivecaesarean section will be randomly allocated into three groups. Group F will receivedintrathecal fentanyl 25 mcg (0.5 ml) along with 1.8 ml of 0.5% hyperbaric levobupivacaine,group D will received intrathecal dexmedetomidine 5 mcg (prepared in 0.5 ml ofnormal saline) along with 1.8 ml of 0.5% levobupivacaine and group C will begiven 0.5 ml of normal saline along with same dose of 0.5% of hyperbaric levobupivacaine.Maximum level of sensory block, time for two segment regression of sensoryblock and duration of motor block will be recorded. Post operative analgesiawill be assessed by using visual analogue score (VAS) and patients complainingof VAS>4 will be given rescue analgesia. Time of first dose ofpost-spinal rescue analgesic will be noted.

 **Expected outcome:** As there is no previous published data comparing fentanyl anddexmedetomidine as adjuvant with 0.5% hyperbaric levobupivacaine, we acceptthat there will be no difference regarding the duration of sensory and motorblock in these two groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-28
• Last Update Posted: 2023-11-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 105

Inclusion Criteria

• ASA grade II 2.
• Age group of 18-30 years 3.
• Body Mass Index between 18.5 and 24.
• Gestational age ≥37 weeks 5.
• Elective lower segment caesarean section under spinal anaesthesia.

Exclusion Criteria

• Patients with severe cardio-respiratory disease 2.
• Patients with hepatic & renal disease 3.
• Patients with neurologic disorder 4.
• Patients with endocrine disorder 5.
• Patients with H/O Antepartum Hemorrhage (APH) 5.
• Subarachnoid block inadequate or failure 6.
• Drug allergy to study drugs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
We are using equipotent dose of fentanyl and dexmedetomidine and both increases the duration of sensory & motor block. we expect both the groups receiving fentanyl and dexmedetomidine will have a longer duration of sensory & motor block compared to patients receiving	September 2022 to February 2024
normal saline as adjuvant but among fentanyl and dexmedetomidine which one will provide longer duration of sensory & motor block will be known after cpmpletion of the study.	September 2022 to February 2024

Secondary Outcome Measures

Name	Time	Method
Duration of surgery	from the beginning to end ot surgery
to measure Systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, respiratory rate, oxygen saturation, VAS Score, ECG	baseline
Apgar score of neonates	at 1 min and 5 min after delivery

Trial Locations

Locations (1)

Midnapore Medical College and Hospital.; 🇮🇳 Medinipur, WEST BENGAL, India

Midnapore Medical College and Hospital.

🇮🇳Medinipur, WEST BENGAL, India

Santanu Saha

Principal investigator

9477428027

santanusaha19@gmail.com