Study to compare how well two medicines midazolam and fentanyl help in relieving post operative pain with minimum side effects when given via an injection in the lower backbone region so that the mother stays awake but feels no pain during delivery of baby by surgical cut in the lower abdomen.

COMPARISON OF POSTOPERATIVE ANALGESIA AND CLINICAL EFFICACY OF MIDAZOLAM WITH FENTANYL AS ADJUVANT TO INTRATHECAL (0.5%)HYPERBARIC BUPIVACAINE IN ELECTIVE CAESAREAN SECTION:A RANDOMIZED CLINICAL STUDY. - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/089949

Enrollment

Registered

2025-07-01

Start date

Unknown

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Health Condition 1: O82- Encounter for cesarean delivery without indication

Interventions

Intervention1: Inj. Bupivacaine Hydrochloride (0.5 percent) (hyperbaric), Inj.midazolam hydrochloride (5mg/ml) (preservative free), 0.9% Sodium Chloride: Intrathecally 10 mg [2.0 ml](0.5%) hyperbaric

Eligibility

Inclusion criteria

Inclusion criteria: Term pregnant women Pregnant women (ASA Physical status II, including women with mild PIH and controlled gestational diabetes) posted for elective caesarean section under spinal anaesthesia Patients who are coming for elective LSCS Those who can give valid informed consent for participation

Exclusion criteria

Exclusion criteria: Patients not willing to give consent Known allergy to amide local anaesthetics, fentanyl, midazolam Patients with contraindications to subarachnoid block Patients with Cardiovascular disease,Severepreeclampsia,Uncontrolled gestational diabetes,Pre-existing neurologic disease Deformities of spinal column in severe degree Emergency LSCS ASA grade III & above Failed spinal anaesthesia Antepartum Haemorrhage Morbidly Obese [ BMI more than equals to 40 kg per square metre ] Incomplete medical record data

Design outcomes

Primary

Measure	Time frame
Duration of postoperative analgesiaTimepoint: From the time of end of surgery till the first demand of rescue analgesic.	—

Secondary

Measure	Time frame
Heart RateTimepoint: Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours.;Systolic Blood PressureTimepoint: Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours.;Diastolic Blood PressureTimepoint: Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours.;Mean Arterial PressureTimepoint: Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours.;Oxygen Saturation (SPO2)Timepoint: Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours.;Respiratory RateTimepoint: Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours.;APGAR Score (Neonatal status)Timepoint: At 1 min,then 5 min after delivery;Visual Analogue Score (Level of pain)Timepoint: Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then 6 hourly thereafter till 24 hours.;Ramsay Sedation Score (Level of sedation)Timepoint: Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours.;Pinprick method (Level of sensory block)Timepoint: Intraoperatively every	—

Measure

Time frame

Heart RateTimepoint: Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours.;Systolic Blood PressureTimepoint: Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours.;Diastolic Blood PressureTimepoint: Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours.;Mean Arterial PressureTimepoint: Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours.;Oxygen Saturation (SPO2)Timepoint: Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours.;Respiratory RateTimepoint: Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours.;APGAR Score (Neonatal status)Timepoint: At 1 min,then 5 min after delivery;Visual Analogue Score (Level of pain)Timepoint: Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then 6 hourly thereafter till 24 hours.;Ramsay Sedation Score (Level of sedation)Timepoint: Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours.;Pinprick method (Level of sensory block)Timepoint: Intraoperatively every

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Countries

India

Contacts

Public ContactDr Diptanu Bhaumik

ICARE Institute Of Medical Sciences and Research and Dr. B. C. Roy Hospital, Haldia

drjayanta60@yahoo.co.in9830022753

Outcome results

None listed

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