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

COMPARISON BETWEEN INTRATHECAL FENTANYL AND DEXMEDETOMIDINE AS AN ADJUVANT TO HYPERBARIC 0.5% LEVOBUPIVACAINE IN SUBARACHNOID BLOCK FOR CEASAREAN SECTION: A PROSPECTIVE STUDY

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/04/051598

Enrollment

105

Registered

2023-04-13

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: 1- Obstetrics

Interventions

Intervention1: Intrathecal fentanyl as adjuvant to Hyperbaric 0.5% levobupivacaine.: Intrathecal Fentanyl 25mcg(0.5ml)along with 1.8ml of 0.5% hyperbaric levobupivacaine in subarachnoid block for elec

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA grade II 2. Age group of 18-30 years 3. Body Mass Index between 18.5 and 24. 4. Gestational age >=37 weeks 5. Elective lower segment caesarean section under spinal anaesthesia

Exclusion criteria

Exclusion criteria: 1. 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. Conversion to general anesthesia 7. Patients with psychiatric problem 8. Any contraindication for spinal anesthesia 9. Drug allergy to study drugs

Design outcomes

Primary

Measure	Time frame
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 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.Timepoint: September 2022 to February 2024	—

Measure

Time frame

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 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.Timepoint: September 2022 to February 2024

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Secondary

Measure	Time frame
Apgar score of neonatesTimepoint: at 1 min and 5 min after delivery;Duration of surgeryTimepoint: 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, ECGTimepoint: baseline every 2 mins for first 10 mins, then every 5 minutes for next 25 mins then every 10 mins till 90 mins during surgery. post operatively every 2 hours till 6 hours	—

Measure

Time frame

Apgar score of neonatesTimepoint: at 1 min and 5 min after delivery;Duration of surgeryTimepoint: 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, ECGTimepoint: baseline every 2 mins for first 10 mins, then every 5 minutes for next 25 mins then every 10 mins till 90 mins during surgery. post operatively every 2 hours till 6 hours

—

Countries

India

Contacts

Public ContactDebasish Bhar

Midnapore Medical College and Hospital

sumanc24@gmail.com9830234881

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026