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

National University of Malaysia (UKM)

Status: Completed

Conditions: Postoperative Shivering

Treatments: Drug: Normal saline; Drug: Phenylephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT04133961

FF-2019-273

Details and patient eligibility

About

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

Full description

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

Enrollment: 118 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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118 participants in 2 patient groups, including a placebo group

Group A (Phenylephrine)

Experimental group

Description:

Phenylephrine infusion started immediately after administration of spinal block

Treatment:

Drug: Phenylephrine

Group B (Saline)

Placebo Comparator group

Description:

Normal saline infusion started immediately after administration of spinal block

Treatment:

Drug: Normal saline