Effect of Different Injection Speeds for Spinal Anaesthesia in Caesarean Section

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02275897
• Other study ID #: NMRR-13-608-16854 (IIR)
• Status: Completed
• Phase: N/A
• First received: October 15, 2014
• Last updated: December 11, 2014
• Start date: March 2013
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: Ministry of Health, Malaysia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Slow Speed of spinal injection
Speed of injection over 60 seconds
• Fast Speed of spinal injection
Speed of injection over 15 seconds

Locations

Country	Name	City	State
Malaysia	Hospital Tengku Ampuan Rahimah	Klang	Selangor

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Health, Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Hypotension	How many patients will experience a drop in systolic Blood Pressure of greater than 20%	First 10 minutes after injection	Yes
Secondary	Use of vasoconstrictors		First 10 minutes after injection	Yes
Secondary	Adequacy of block	To determine if the anaesthetic is adequate for the surgery (no pain or movement experienced around the surgical field)	Time of surgery	Yes