Intraoperative Phenylephrine Infusion to Reduce Postoperative Shivering in Lower Segment Caesarean Section

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-12

Study Completion Date

2020-01-01

Brief Summary

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Assessment of whether and how phenylephrine infusion reduces postoperative shivering in spinal anaesthesia.

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Detailed Description

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This study aims to evaluate whether phenylephrine infusion can reduce postoperative shivering among patients scheduled for elective lower segment caesarean section under spinal anaesthesia.

Conditions

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Postoperative Shivering

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Group A (Phenylephrine)

Phenylephrine infusion started immediately after administration of spinal block

Group Type EXPERIMENTAL

Phenylephrine

Intervention Type DRUG

Phenylephrine infusion 0.3ml/kg/hour (equivalent to 0.5mcg/kg/min, phenylephrine dilution is 100mcg/ml in 20ml syringe)

Group B (Saline)

Normal saline infusion started immediately after administration of spinal block

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Normal saline infusion 0.3ml/kg/hour (normal saline in 20ml syringe)

Interventions

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Phenylephrine

Phenylephrine infusion 0.3ml/kg/hour (equivalent to 0.5mcg/kg/min, phenylephrine dilution is 100mcg/ml in 20ml syringe)

Intervention Type DRUG

Normal saline

Normal saline infusion 0.3ml/kg/hour (normal saline in 20ml syringe)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* More than 18 years of age
* American Society of Anesthesiologists (ASA) II patients
* Patients with singleton pregnancy who are scheduled to undergo elective lower segment caesarean section under spinal anaesthesia

Exclusion Criteria

* Patients with contraindication to phenylephrine
* Patients with evidence of fever or infection, or hypothermia preoperatively
* BMI ≥ 40
* Height \<150cm

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No