Comparison of Meperidine and Sufentanil Added to 0.5% Hyperbaric Bupivacaine for Spinal Anesthesia in Cesarean Section

Overview

Subarachnoid block is a widely used anesthetic technique for cesarean section. To improve the quality of analgesia and prolong its duration, the addition of intrathecal opioids to local anesthetics has been encouraged. In a double blind randomized controlled trial, 60 parturient women ASA 2-3 scheduled for elective cesarean delivery under spinal anesthesia will be randomly divided into 2 groups: Group 1 will receive sufentanil 5 μg and Group 2 will receive meperidine 12.5 mg. In every group, 0.5% heavy bupivacaine 10 will be added.

Full Title of Study: “Comparison of Clinical Effects of Meperidine and Sufentanil Added to 0.5% Hyperbaric Bupivacaine for Spinal Anesthesia in Patients Undergoing Cesarean Section”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2021

Detailed Description

A questionnaire will be used to collect data. Patients' demographic and operative characteristics will be recorded. These include block level, heart rate, mean arterial pressure, nausea, vomiting, shivering and use of vasopressors. Post-operative data include pain, analgesic consumption, nausea and vomiting, as well as patients and surgeons satisfaction.

Interventions

  • Drug: sufentanil
    • Patients will receive sufentanil in spinal anesthesia
  • Drug: meperidine
    • Patients will receive meperidine in spinal anesthesia
  • Drug: Bupivacaine
    • Patients will receive 0.5% heavy bupivacaine in spinal anesthesia

Arms, Groups and Cohorts

  • Experimental: Sufentanil Group
    • Patients will receive sufentanil 5 μg in addition to 0.5% heavy bupivacaine spinal anesthesia
  • Experimental: Meperidine Group
    • Patients will receive meperidine 12.5 mg in addition to 0.5% heavy bupivacaine spinal anesthesia

Clinical Trial Outcome Measures

Primary Measures

  • First analgesic request time
    • Time Frame: 24 hours post operatively
    • The duration of effective analgesia is defined as the time from intrathecal injection to first patient analgesic demand

Secondary Measures

  • Analgesic requirements
    • Time Frame: 24 hours post operatively
    • A questionnaire will be used to record the analgesics consumed by the patients

Participating in This Clinical Trial

Inclusion Criteria

  • pregnant women with American Society of Anesthesiologist (ASA) 2-3 – scheduled for elective cesarean section. Exclusion Criteria:

  • refuse to participate in the study, – requiring emergency obstetric care, – ASA IV or V, – having systemic diseases, – a known fetal anomaly, – placenta previa, – abruption placenta – with a history of hypersensitivity or allergy to any of the study drugs, – operation time longer than 1.5 hour, – blood loss more than 1500 millilitres, – those with any contraindication to the technique proposed,

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Makassed General Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Saleh Kanawati, Acting chairperson – Makassed General Hospital
  • Overall Official(s)
    • Saleh Kanawati, MD, Principal Investigator, Makassed General Hospital
  • Overall Contact(s)
    • Saleh Kanawati, MD, +9611636000, s.kanawati@hotmail.com

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