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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sufentanil Group

Patients will receive sufentanil 5 μg in addition to 0.5% heavy bupivacaine spinal anesthesia

Group Type EXPERIMENTAL

sufentanil

Intervention Type DRUG

Patients will receive sufentanil in spinal anesthesia

Bupivacaine

Intervention Type DRUG

Patients will receive 0.5% heavy bupivacaine in spinal anesthesia

Meperidine Group

Patients will receive meperidine 12.5 mg in addition to 0.5% heavy bupivacaine spinal anesthesia

Group Type EXPERIMENTAL

meperidine

Intervention Type DRUG

Patients will receive meperidine in spinal anesthesia

Bupivacaine

Intervention Type DRUG

Patients will receive 0.5% heavy bupivacaine in spinal anesthesia

Interventions

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sufentanil

Patients will receive sufentanil in spinal anesthesia

Intervention Type DRUG

meperidine

Patients will receive meperidine in spinal anesthesia

Intervention Type DRUG

Bupivacaine

Patients will receive 0.5% heavy bupivacaine in spinal anesthesia

Intervention Type DRUG

Eligibility Criteria

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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,

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No