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Effect of Intrathecal Naloxone in the Incidence of Pruritis After C.S

NCT04518618 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2021-03-26

No results posted yet for this study

Summary

This randomized prospective double-blind trial will be conducted on 80 Full-term pregnant females aged 21- 30 years presented for elective cesarean section under spinal anesthesia where they will be randomly allocated into two equal groups:-

* Group F (40 Patients): Patients in this group will receive spinal anesthesia with 10 mg hyperbaric bupivacaine (2 ml) plus 25 ug of fentanyl (0.5 ml).
* Group FN (40 patients): Patients in this group will receive spinal anesthesia with 10 mg hyperbaric bupivacaine (2 ml) plus 25 ug of fentanyl (0.5 ml) plus 20 ug naloxone.

The study aim is to evaluate the effect of adding an ultra-low dose of naloxone (20 ug) to hyperbaric bupivacaine (10 mg0 and fentanyl (25 ug) in spinal anesthesia for C.S.

Primary outcome: The incidence of pruritis Secondary outcome: The onset, the duration, the site, and the severity of pruritis.

Conditions

  • Pruritis

Interventions

DRUG

Fentanyl

Spinal anesthesia will be performed with injection of 2.5 ml which will be composed of 10 mg hyperbaric bupivacaine (2 ml) and 25 ugs fentanyl (0.5 ml)

DRUG

Naloxone

Spinal anesthesia will be performed with injection of 2.5 ml which will be composed of 10 mg hyperbaric bupivacaine (2 ml) and fentanyl 25 ug combined with 20 ugs naloxone in 0.5 ml

Sponsors & Collaborators

  • Tanta University

    lead OTHER

Principal Investigators

  • Sameh Abdelkhalik, M.D · Tanta University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
30 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-11
Primary Completion
2021-03-07
Completion
2021-03-07

Countries

  • Egypt

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04518618 on ClinicalTrials.gov