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Effect of Different Injection Speeds for Spinal Anaesthesia in Caesarean Section

NCT ID: NCT02275897

Last Updated: 2014-12-12

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

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-11-30

Brief Summary

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The purpose of this study is to investigate if prolonging the speed of injection during spinal anaesthesia can reduce the incidence of hypotension and/or medication requirements thereby making it safer for the mother and foetus.

Detailed Description

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We plan to investigate if by varying the speed of injection during spinal anaesthesia, will there be a difference in the incidence of hypotension. Hypotension is a common complication especially for pregnant women undergoing caesarean section. A high speed of injection can theoretically cause a higher spread of anaesthetic, which may increase the incidence of hypotension. We want to know if by prolonging the injection time, will this lead to a reduction in a rate of hypotension.

Conditions

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Pregnancy Effects of; Anesthesia, Spinal and Epidural; in Pregnancy

Keywords

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Lower Segmental Caesarean Section (LSCS) Speed of Injection Spinal Anaesthesia Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Slow Speed

Slow group patients will receive spinal injection over 60 seconds. Vital signs monitored every minute after injection. Hypotension is treated with IV Phenylephrine or Ephedrine.

Group Type EXPERIMENTAL

Slow Speed of spinal injection

Intervention Type PROCEDURE

Speed of injection over 60 seconds

Fast Speed

Fast group patients will receive spinal injection over 15 seconds. Vital signs monitored every minute after injection. Hypotension is treated with IV Phenylephrine or Ephedrine.

Group Type EXPERIMENTAL

Fast Speed of spinal injection

Intervention Type PROCEDURE

Speed of injection over 15 seconds

Interventions

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Slow Speed of spinal injection

Speed of injection over 60 seconds

Intervention Type PROCEDURE

Fast Speed of spinal injection

Speed of injection over 15 seconds

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* at least 18 years of age
* singleton term pregnancy
* American Society of Anesthesiologists (ASA) class I-II

Exclusion Criteria

* Severe pre-eclampsia
* contraindications to spinal anaesthesia
* Height \<150cm or \>180cm
* Weight ≥100kg
* Baseline systolic BP \<90 mmHg
* Baseline systolic BP \>150mmHg
* Category 1 urgency for delivery
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Health, Malaysia

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Chiang CF

Medical Officer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chun Fai Chiang, MBBS

Role: PRINCIPAL_INVESTIGATOR

Ministry of Health, Malaysia

Locations

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Hospital Tengku Ampuan Rahimah

Klang, Selangor, Malaysia

Site Status

Countries

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Malaysia

References

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Chiang CF, Hasan MS, Tham SW, Sundaraj S, Faris A, Ganason N. Injection speed of spinal anaesthesia for Caesarean delivery in Asian women and the incidence of hypotension: A randomised controlled trial. J Clin Anesth. 2017 Jun;39:82-86. doi: 10.1016/j.jclinane.2017.03.025. Epub 2017 Apr 1.

Reference Type DERIVED
PMID: 28494915 (View on PubMed)

Other Identifiers

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NMRR-13-608-16854 (IIR)

Identifier Type: -

Identifier Source: org_study_id