Comparative Study of Fentanyl vs Dexmedetomidine as Adjuvants to Intrathecal Bupivacaine in Cesarean Section

NCT06785285 | Completed DMC

• 1 other identifier: Nehal Samir
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The quality of the spinal anesthesia has beenreported to be improved by the addition of opioids (such as morphine, fentanyl and sufentanil) and other drugs (such as dexmedetomidine, clonidine, magnesium sulfate (Mg), neostigmine, ketamine, and midazolam). Opioids such as fentanyl in combination with bupivacaine improvesthe quality of intraoperative and early postoperative subarachnoid block. Although, fentanylensures superior quality of analgesia, it is associated with many side effects. This has directed theresearch toward the use of newer and betteradjuvants for spinal anesthesia such as clonidineand dexmedetomidine

Conditions

Cesarean Section

Outcome Measures

Primary Outcomes (1)

• Pain Relief

  Patient's pain score will be assessed using visual analogue scale (VAS); scored from 0-10 (where 0=no pain and 10=the worst pain imaginable) during the recovery room (T0) and at one, three, and six hours (T1, T3, and T6) in the postoperative period.

  from 0 hours to 6 hours after the procedure

Study Arms (2)

Group A

ACTIVE COMPARATOR

About 30 patients received Dexmeditomidine 5 ug and added to it 10 mg hyperbaric bupivicaine 0.5 % .

Drug: Dexmedetomidine

Group B

ACTIVE COMPARATOR

About 30 patients received fentanyl 25 ug and added to it 10 mg hyperbaric bupivicaine 0.5 % .

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

To compare the effects of fentanyl and dexmedetomidine when used as adjuvants to intrathecal bupivacaine in elective cesarean section, assessing their impact on the onset and duration of spinal anesthesia, quality of analgesia, hemodynamic stability, incidence of side effects, and neonatal outcomes

Also known as: fentanyl 25 ug

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women in the childbearing period
• aged 18 to 40 years
• Gestational age ≥37 weeks of pregnancy
• ASA I and II candidates for elective cesarean section under spinal anesthesia.

You may not qualify if:

• The patients with emergency conditions,
• Contraindication of spinal anesthesia,
• History of valvular heart disease,
• History of allergy or sensitivity to applied drugs and
• Patients with placenta previa
• Failed blockade or need for induction of general anesthesia

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Fentanyl

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Study Officials

• Nehal samir esmail, Lecturer

  Sohag University, Faculty of medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, intensive care and pain management Faculty of Medicine

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: January 21, 2025
• Study Start: March 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 10, 2024
• Last Updated: January 21, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)