Effect of Different Injection Speeds for Spinal Anaesthesia in Caesarean Section

December 11, 2014 updated by: Dr. Chiang CF, Ministry of Health, Malaysia

Injection Speed of Spinal Anaesthesia for Asian Women Undergoing Lower Segmental Caesarean Section and the Incidence of Hypotension and/or Use of Vasopressors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Selangor
      • Klang, Selangor, Malaysia, 41200
        • Hospital Tengku Ampuan Rahimah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Slow Speed of spinal injection
Speed of injection over 60 seconds
Experimental: 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.
Procedure: Fast Speed of spinal injection
Speed of injection over 15 seconds

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Hypotension
Time Frame: First 10 minutes after injection
How many patients will experience a drop in systolic Blood Pressure of greater than 20%
First 10 minutes after injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of vasoconstrictors
Time Frame: First 10 minutes after injection
First 10 minutes after injection
Adequacy of block
Time Frame: Time of surgery
To determine if the anaesthetic is adequate for the surgery (no pain or movement experienced around the surgical field)
Time of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ministry of Health, Malaysia

Investigators

  • Principal Investigator: Chun Fai Chiang, MBBS, Ministry of Health, Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

October 15, 2014

First Submitted That Met QC Criteria

October 23, 2014

First Posted (Estimate)

October 27, 2014

Study Record Updates

Last Update Posted (Estimate)

December 12, 2014

Last Update Submitted That Met QC Criteria

December 11, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMRR-13-608-16854 (IIR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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