Intrathecal Injection of Hyperbaric Bupivacaine Versus a Mixture of Hyperbaric and Isobaric Bupivacaine in Patients Undergoing Lower Abdominal Surgery

NCT06050044 | Completed

• 1 other identifier: 48-2022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the effects of intrathecal injection of hyperbaric bupivacaine versus injection of hyperbaric and isobaric bupivacaine in patients undergoing lower abdominal surgery.

Conditions

Spinal Anesthesia; Hyperbaric Bupivacaine; Isobaric Bupivacaine; Lower Abdominal Surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of hypotension

  Blood pressure was recorded using standard non-invasive monitors at 5, 10, 15, 20, 25, 30, 45, and 60 min, then hourly until 3 h post-injection. Hypotension was defined as a decrease in mean arterial pressure of more than 30% from baseline.

  3 hours post-injection

Secondary Outcomes (2)

• Heart rate

  3 hours post-injection

• Mean arterial pressure (MAP)

  3 hours post-injection

Study Arms (2)

Group A (hyperbaric bupivacaine)

EXPERIMENTAL

Patients were injected intrathecally with 20 mg hyperbaric bupivacaine 0.5% solution.

Drug: Group A (hyperbaric bupivacaine)

Group B (Mixture of Hyperbaric and Isobaric Bupivacaine)

EXPERIMENTAL

Patients received 10 mg hyperbaric bupivacaine and 10 mg isobaric bupivacaine 0,5 % solution.

Drug: Group B (Mixture of Hyperbaric and Isobaric Bupivacaine)

Interventions

Group A (hyperbaric bupivacaine) DRUG

Patients were injected intrathecally with 20 mg hyperbaric bupivacaine 0.5% solution

Group A (hyperbaric bupivacaine)

Group B (Mixture of Hyperbaric and Isobaric Bupivacaine) DRUG

Patients received 10 mg hyperbaric bupivacaine and 10 mg isobaric bupivacaine 0,5 % solution

Group B (Mixture of Hyperbaric and Isobaric Bupivacaine)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18-65 years old.
• Both sexes.
• American Society of Anaesthesia (ASA) I to II.
• Undergoing lower abdominal or urological surgery under spinal anesthesia

You may not qualify if:

• Allergy to amide.
• Patients with a significant history of substance abuse.
• Patients with diabetes mellitus, neurological or cardiovascular diseases.
• Patients with neuromuscular diseases.
• Pregnant patients.

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

Helwan University

Helwan, Cairo Governorate, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, Surgical Intensive Care and Pain Management, Faculty of Medicine, Helwan University

Study Record Dates

• First Submitted: September 17, 2023
• First Posted: September 22, 2023
• Study Start: May 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)