NCT04133961

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 12, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 21, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

July 8, 2020

Status Verified

October 1, 2019

Enrollment Period

6 months

First QC Date

October 11, 2019

Last Update Submit

July 5, 2020

Conditions

Postoperative Shivering

Keywords

PhenylephrineSpinal anaesthesia

Outcome Measures

Primary Outcomes (1)

  • Presence and intensity of shivering

    Any presence of shivering intraoperatively is recorded. The intensity of shivering is recorded based on the Bedside Shivering Assessment Scale (BSAS) with a scoring of 0-3 (0 = no shivering, 1 = shivering localised to neck and/or thorax, 2 = shivering involves gross movement of upper extremities, 3 = shivering involves gross movements of the trunk, upper and lower extremities).

    2 hours

Secondary Outcomes (1)

  • Change in patient's core and skin temperature

    2 hours

Study Arms (2)

Group A (Phenylephrine)

EXPERIMENTAL

Phenylephrine infusion started immediately after administration of spinal block

Drug: Phenylephrine

Group B (Saline)

PLACEBO COMPARATOR

Normal saline infusion started immediately after administration of spinal block

Drug: Normal saline

Interventions

PhenylephrineDRUG

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

Group A (Phenylephrine)
Normal salineDRUG

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

Group B (Saline)

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPatients who are planned for elective lower segment caesarean section
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pusat Perubatan Universiti Kebangsaan Malaysia

Kuala Lumpur, 56000, Malaysia

Location

Related Publications (4)

  • Ikeda T, Ozaki M, Sessler DI, Kazama T, Ikeda K, Sato S. Intraoperative phenylephrine infusion decreases the magnitude of redistribution hypothermia. Anesth Analg. 1999 Aug;89(2):462-5. doi: 10.1097/00000539-199908000-00040.

    PMID: 10439767BACKGROUND

  • Ro Y, Huh J, Min S, Han S, Hwang J, Yang S, Kim DK, Kim C. Phenylephrine attenuates intra-operative hypothermia during spinal anaesthesia. J Int Med Res. 2009 Nov-Dec;37(6):1701-8. doi: 10.1177/147323000903700605.

    PMID: 20146867BACKGROUND

  • Hilton EJ, Wilson SH, Wolf BJ, Hand W, Roberts L, Hebbar L. Effect of Intraoperative Phenylephrine Infusion on Redistribution Hypothermia During Cesarean Delivery Under Spinal Anesthesia. J Clin Anesth Manag. 2016 Jan;1(1):10.16966/2470-9956.103. doi: 10.16966/2470-9956.103. Epub 2015 Dec 19.

    PMID: 32500108BACKGROUND

  • Badjatia N, Strongilis E, Gordon E, Prescutti M, Fernandez L, Fernandez A, Buitrago M, Schmidt JM, Ostapkovich ND, Mayer SA. Metabolic impact of shivering during therapeutic temperature modulation: the Bedside Shivering Assessment Scale. Stroke. 2008 Dec;39(12):3242-7. doi: 10.1161/STROKEAHA.108.523654. Epub 2008 Oct 16.

    PMID: 18927450BACKGROUND

MeSH Terms

Interventions

PhenylephrineSaline Solution

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Syarifah Noor Nazihah Sayed Masri, MD

    Anaesthesiologist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2019

First Posted

October 21, 2019

Study Start

June 12, 2019

Primary Completion

December 1, 2019

Study Completion

January 1, 2020

Last Updated

July 8, 2020

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)