Effect of Different Injection Speeds for Spinal Anaesthesia in Caesarean Section

Not Applicable

Completed

• Conditions: Effects of; Anesthesia, Spinal and Epidural; in Pregnancy; Pregnancy
• Interventions: Procedure: Slow Speed of spinal injection; Procedure: Fast Speed of spinal injection

• Registration Number: NCT02275897
• Lead Sponsor: Ministry of Health, Malaysia

Brief 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.

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 Timeline

• Study Start: 2013-03
• Study First Submitted: 2014-10-15
• Study First Submitted QC: 2014-10-23
• Study First Posted: 2014-10-27
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-11
• Last Update Posted: 2014-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 77

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Slow Speed	Slow Speed of spinal injection	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.
Fast Speed	Fast Speed of spinal injection	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.

Primary Outcome Measures

Name	Time	Method
Incidence of Hypotension	First 10 minutes after injection	How many patients will experience a drop in systolic Blood Pressure of greater than 20%

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Tengku Ampuan Rahimah; 🇲🇾 Klang, Selangor, Malaysia