A study where we are comparing the efficacy of intravenous infusion of Tramadol versus Phenylephrine versus Dexmedetomidine for prevention of shivering during OT in a primigravida undergoing caesarean section after spinal anaesthesia

Comparative study between intravenous infusions 0f tramadol versus phenylephrine versus dexmedetomidine for prophylaxis of postspinal intraoperative shivering in primigravida undergoing caesarean section - nil

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/06/112751

Enrollment

Registered

2026-06-15

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Health Condition 1: O295- Other complications of spinal andepidural anesthesia during pregnancy

Interventions

Intervention1: Group T : Group T(no=20) will receive inj Tramadol 0.25mg/kg/hr iv infusion before 10min of spinal anaesthesia @10ml/hr Intervention2: group D: Group D(no=20) will receive inj Dexmede

Eligibility

Inclusion criteria

Inclusion criteria: 1. Aged from 18 to 35 years. 2. American Society of Anaesthesiologists class II and class III 3. Singleton and full- term pregnancy. 4. Patients giving valid consent 5.Operation Duration within 90 minutes

Exclusion criteria

Exclusion criteria: 1. Patient s refusal. 2. Patients with uncontrolled medical condition 3. Obstetric complications like breech presentation, twin pregnancy, placenta previa, placental abruption, pregnancy induced hypertension (PIH). 4. Patients with autonomic neuropathy, spinal deformity or coagulation abnormality. 5. Patients with neonatal compromise like foetal bradycardia meconium-stained liquor, IUGR. 6. Failed spinal, repeat spinal, patchy spinal, conversion to general anaesthesia at any moment of surgery is excluded from study. 7. Patient with history of allergy to study drugs 8. Height less than 150 cm and more than 180 cm 9. Body mass index more than 30 kg per m2, 10. With fever (axillary temperature more than 37 degree Celsius) or shivering.

Design outcomes

Primary

Measure	Time frame
The primary outcome of this trial is the incidence of shivering among groupsTimepoint: Study end point will be the time from starting of infusion to when shivering occurs in OT.	—

Secondary

Measure	Time frame
1. The severity of shivering. 2. Monitoring vital parameters like MAP, HR, SpO2 at specific time interval 3. Record adverse effect like intra operative nausea, vomiting ,bradycardia dryness of mouth ,sedation and others 4. Measure surface and core temperature during pre and intra op Timepoint: Study end point will be the time from starting of infusion to when shivering occurs in OT. Blood pressure ,Heart rate ,Temperature , Saturation noted in 5 min interval after intrathecal injection till baby delivery, hen every 10 min till OT ends.	—

Measure

Time frame

1. The severity of shivering. 2. Monitoring vital parameters like MAP, HR, SpO2 at specific time interval 3. Record adverse effect like intra operative nausea, vomiting ,bradycardia dryness of mouth ,sedation and others 4. Measure surface and core temperature during pre and intra op Timepoint: Study end point will be the time from starting of infusion to when shivering occurs in OT. Blood pressure ,Heart rate ,Temperature , Saturation noted in 5 min interval after intrathecal injection till baby delivery, hen every 10 min till OT ends.

—

Countries

India

Contacts

Public ContactRanadeep Sarkar

Midnapore Medical College And hospital

drnilambar@gmail.com9883258680

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026