Fentanyl Versus Dexmedetomidine as an Adjuvant to Bupivacaine in Spinal Anesthesia ; Peritoneal Symptomatic Effects

NCT06386783 | Recruiting Phase 3

• 1 other identifier: Asw.U./823 /7/23
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

To compare whether 5 μg dexmedetomidine with 25 μg fentanyl added to 0.5% hyperbaric bupivacaine as adjuvants in spinal anaesthesia in patients undergoing appendectomy could reduce intraoperative peritoneal related symptoms.

Conditions

Dexmedetomidine; Fentanyl

Keywords

Peritoneal symptoms; Spinal ansthesia; Appendectomy

Outcome Measures

Primary Outcomes (1)

• intraoperative peritoneal symptoms during appendectomy.

  Compare between the efficacy of dexmedetomidine and fentanyl as adjuvants on decreasing the intraoperative peritoneal symptoms such as abdominal discomfort or visceral pain, nausea and vomiting, vagal symptoms like bradycardia and hypotension during appendectomy.

  Intraoperative period in minutes

Secondary Outcomes (3)

• Assessment of motor block with Modified Bromage scale

  1,6,12,18 and 24 hours

• Degree of post-operative analgesia

  1,6,12,18 and 24 hours

• Assessment of sensory block by using pin prick method

  Time in minutes

Study Arms (2)

Group D (N.74)

ACTIVE COMPARATOR

5µg Dexmedetomidine {precedexTM 200U/2ml Hospira, Inc,lake forest,iL,USA} (5 µg added by taking 50 µg in a insulin syringe) + 4ml 0.5% heavy bupivacaine HCl.

Drug: Dexmedetomidine Injection [Precedex]

Group F (N.74) -

ACTIVE COMPARATOR

25 µg Fentanyl {fentanyl Hameln 50 u/ml Gmbh-germany} + 4ml 0.5% heavy bupivacaine HCl.

Drug: Fentanyl HCl

Interventions

Dexmedetomidine Injection [Precedex] DRUG

Compare between the efficacy of dexmedetomidine and fentanyl as adjuvants on decreasing the intraoperative peritoneal symptoms such as abdominal discomfort or visceral pain, nausea and vomiting, vagal symptoms like bradycardia and hypotension during appendectomy.

Group D (N.74)

Fentanyl HCl DRUG

Compare between the efficacy of dexmedetomidine and fentanyl as adjuvants on decreasing the intraoperative peritoneal symptoms such as abdominal discomfort or visceral pain, nausea and vomiting, vagal symptoms like bradycardia and hypotension during appendectomy.

Group F (N.74) -

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA physical status class I and II.
• Age between 18 - 60 years of either sex.

You may not qualify if:

• ASA grade III and IV.
• Infection at the site of injection.
• Coagulopathy or anticoagulation.
• Congenital anomalies of lower spine.
• Active disease of CNS.
• History of allergy to local anesthetics or the adjuvants.
• Complicated appendicitis.

Sponsors & Collaborators

• Aswan University: lead

Study Sites (1)

Aswan University

Aswān, Aswan Governorate, 81528, Egypt

RECRUITING

Related Publications (2)

• Minagar M, Alijanpour E, Jabbari A, Rabiee SM, Banihashem N, Amri P, Mir M, Hedayati Goodarzi MT, Esmaili M. The efficacy of addition of dexmedetomidine to intrathecal bupivacaine in lower abdominal surgery under spinal anesthesia. Caspian J Intern Med. 2019 Spring;10(2):142-149. doi: 10.22088/cjim.10.2.142.

  PMID: 31363392 BACKGROUND

• Gupta R, Verma R, Bogra J, Kohli M, Raman R, Kushwaha JK. A Comparative study of intrathecal dexmedetomidine and fentanyl as adjuvants to Bupivacaine. J Anaesthesiol Clin Pharmacol. 2011 Jul;27(3):339-43. doi: 10.4103/0970-9185.83678.

  PMID: 21897504 BACKGROUND

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ayman M Eldemrdash, MD

  Aswan University

  PRINCIPAL INVESTIGATOR

• Ahmed A Mahmoud, MD

  Aswan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soudy S Hammad, MD

CONTACT

+201014761523; soudi.salah@aswu.edu.eg

Ahmed M Hagag, MSc

CONTACT

01141097536

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: concealed based on study drugs assigned to each group \& to conduct this double -blinded clinical trials, our study drugs will be prepared by the senior anesthesiologist who won't be involved in further observations of the patients and neither patients nor outcome assessor will be aware of which drugs they will receive.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia and surgical intensive care

Model Details: This randomized double blinded study will be conducted at Aswan university hospitals at patients scheduled for emergency appendectomy

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 26, 2024
• Study Start: July 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: February 25, 2025
• Last Updated: February 21, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)