The Effects of Keeping the Patient in a Sitting Position for One Minute After Spinal Anesthesia

The Effects of Keeping the Patient in a Sitting Position for One Minute After Spinal Anesthesia on Hypotension, Nausea-vomiting and Ephedrine Consumption

The aim of this study was to examine the effect of keeping the patient in a sitting position for 1 minute after spinal anaesthesia in elective caesarean operations, primarily on the formation of hypotension and secondarily on nausea-vomiting, the need for ephedrine and the block characteristics.

Study Overview

• Status: Completed
• Conditions: Hypotension; Spinal Anaesthesia
• Intervention / Treatment: Procedure: sitting position; Procedure: supine position

• Study Type: Interventional
• Enrollment (Actual): 214
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• aged 18 - 45 years,
• ASA physical status
• I - II,
• BMI of 25-30
• who were undergoing elective CS

Exclusion Criteria:

• vertebral anomaly,
• peripheral vascular disease,
• cardiovascular or psychiatric disorder,
• severe anemia,
• coagulopathy
• infection in the intervention region

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; 12.5 mg 0.5% hyperbaric bupivacaine	Procedure: sitting position; keeping the patient in a sitting position after spinal anaesthesia
Active Comparator: Group 2; 10 mg 0.5% hyperbaric bupivacaine	Procedure: supine position; keeping the patient in supine position after spinal anaesthesia
Active Comparator: Group 3; 12.5 mg 0.5% hyperbaric bupivacaine	Procedure: supine position; keeping the patient in supine position after spinal anaesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
systolic arterial hypotension	reduction of >25% in the basal systolic arterial pressure	every 3 minutes until the delivery and every 5 minutes until the end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sensory block	assesment of the time to reach T12 level with pin prick test	10 minutes after spinal block
ephedrine requirement time	the time to first administration of ephedrine as minutes after spinal block	1 hour after spinal block
amount of ephedrine	administrated total ephedrine dosage as mg during surgery	1 hour after spinal block
surgeon and patient satisfaction	1= poor, 2=fair, 3= good, 4= very good	24 hours after spinal block
motor block	time to Bromage Score 0 after applying spinal block	24 hours after spinal block

Collaborators and Investigators

• Sponsor: Umraniye Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: February 5, 2019
• First Submitted That Met QC Criteria: February 6, 2019
• First Posted (Actual): February 7, 2019

Study Record Updates

• Last Update Posted (Actual): February 7, 2019
• Last Update Submitted That Met QC Criteria: February 6, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: spinal anaesthesia; ephedrine
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: GK12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No