Comparing Sitting Versus Lateral Position During Spinal Anesthesia on the Severity of Hypotension:

NCT06149572 | Unknown DMC

• 1 other identifier: 0778
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to assess the effect of sitting and lateral positions on the severity of hypotension during the initiation of spinal anesthesia in elective cesarean section. There will be Sitting and Lateral groups in the study.

Conditions

Severty of Hpotention

Keywords

Hypotention; Ethiopia; Dessie

Outcome Measures

Primary Outcomes (1)

• Effect of Positioning on the Severity of Spinal-Induced Hypotension

  severity of hypotension will be measured by blood pressure as it defined milled hypotension when mean arterial pressure is 20% below the baseline, moderate hypotension when below 20% to 30% and Severe hypotension is a decrease of mean arterial pressure greater than 30% below the Baseline

  Each participant will be followed 4 weeks

Secondary Outcomes (3)

• Consumption of vasopressor.

  Each participant will be followed a minimun of 4 weeks

• Grade of motor blockage:

  Each participant will be followed 4 weeks

• level of sensory block:

  Each participant will be followed 4 weeks

Study Arms (2)

Lateral (L) Position group

EXPERIMENTAL

Parturients will be put for spinal punctures at the lateral position

Procedure: lateral position procedure

Sitting (S)position group

ACTIVE COMPARATOR

Parturients will get spinal punctures at the Sitting position as comparison

Procedure: sitting position porocedure

Interventions

lateral position procedure PROCEDURE

Lateral positioning will be used as an intervention for spinal hypotension.

Lateral (L) Position group

sitting position porocedure PROCEDURE

parturients will get spinal punctures in the sitting position

Sitting (S)position group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- American Society of Anesthesiologists Physical Status (ASA II)

You may not qualify if:

• Any contraindication for spinal anesthesia
• History of Hypertensive disorders, anemia, Heart disease, diabetes and placenta previa
• poly- or oligo-hydramnios
• Obesity (BMI ≥29-35 kg/m2)
• Height \<155 cm
• multiple pregnancy
• Sample size and sampling procedure

Sponsors & Collaborators

• Wollo University: lead

Study Sites (1)

Dessie comprehensive specilized hospital

Dessie, Amhara, 801103, Ethiopia

Location

Study Officials

• Aynalem Woldemichael, MSC

  Wollo Universty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The data collector and primary investigators will be blinded for the position of parturient
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Woldemichael

Model Details: the sitting and lateral groups followed and assessed parallelly

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: November 29, 2023
• Study Start: November 25, 2023
• Primary Completion: May 1, 2024
• Study Completion: June 1, 2024
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

ET (1)