Combined Spinal Epidural Anesthesia in Obese Patients Undergoing Cesarean Surgery

NCT04612998 | Completed

• 1 other identifier: B.30.2.ATA.0.01.00/11
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigated the maternal and fetal effects during performance of CSEA in the left lateral decubitus and sitting positions in obese pregnant women undergoing elective cesarean section.

Conditions

Obesity; Pregnancy Related; Cesarean Section Complications; Spinal Anaesthetic Poisoning of Undetermined Intent; Hypotension

Keywords

Combined spinal epidural anesthesia; obesity; cesarean section; lateral decubitus position; sitting position; hypotension

Outcome Measures

Primary Outcomes (1)

• ephedrine requirement

  The change in ephedrine requirement during surgery (mg).

  Every two minutes during surgery.

Secondary Outcomes (2)

• atropine requirement

  every two minutes during surgery

• analgesic requirement

  every five minutes after surgery.

Study Arms (2)

Comparator group

SHAM COMPARATOR

Comparator group consisted of patients performing CSEA in the left lateral decubitus position.

Other: left lateral decubitus position; Drug: The use of intravenous ephedrine.; Drug: The use of intravenous atropine.; Drug: The use of intravenous metoclopramide

Active control group

ACTIVE COMPARATOR

Active control group consisted of patients performing CSEA in the sitting position.

Other: sitting position; Drug: The use of intravenous ephedrine.; Drug: The use of intravenous atropine.; Drug: The use of intravenous metoclopramide

Interventions

left lateral decubitus position OTHER

Comparator group consisted of patients performing CSEA in the left lateral decubitus position.

Comparator group

sitting position OTHER

Active control group consisted of patients performing CSEA in the sitting position.

Active control group

The use of intravenous ephedrine. DRUG

Intravenous ephedrine (6 mg) was used to treat hypotension (a 30% decrease in systolic blood pressure compared to preoperative values) during surgery.

Active control group; Comparator group

The use of intravenous atropine. DRUG

Intravenous atropine (1 mg) was given in case of bradycardia (the heart rate \< 45 beats/minute) during surgery.

Active control group; Comparator group

The use of intravenous metoclopramide DRUG

When nausea and vomiting were observed, intravenous metoclopramide (10 mg) was administered.

Active control group; Comparator group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: obese women with full-term gestation
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• obese women with full-term gestation
• aged between 18-45 years
• ASA (American society of anesthesiologist) I and II
• undergoing elective cesarean section with combined spinal-epidural anesthesia

You may not qualify if:

• psychiatric diseases
• preeclampsia
• pregnancy-induced hypertension
• chronic hypertension
• diabetes
• multiple pregnancies
• fetal anomaly
• allergy to study drugs

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Mehmet AKSOY

Erzurum, string:Turkey, 25240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity; Hypotension

Interventions

Sitting Position

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mehmet AKSOY

  Faculty of Medicine, Ataturk University, Erzurum, Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In the recovery room, Visual analogue scale (VAS, 0 cm= no pain, 10 cm= worst pain) scores for pain severity, anesthesia-related side effects (e.g., nausea, vomiting and headache), sensory block time (from the spinal injection to the recovery of T10 dermatome), and the time requiring supplemental analgesics was recorded by an independent observer blinded to the group assignment at 30 min and 1st and 2nd hours post-operatively.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr. Mehmet AKSOY

Model Details: Comparator group consisted of patients performing CSEA in the left lateral decubitus position. Active control group consisted of patients performing CSEA in the sitting position.

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: November 3, 2020
• Study Start: February 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: April 5, 2018
• Last Updated: November 3, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)