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

Fentanyl Versus Dexmedetomidine As an Adjuvant to Bupivacaine in Spinal Anaesthesia for Appendectomy Patients; Peritoneal Symptomatic Effects: a Randomized Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Dexmedetomidine; Fentanyl
• Intervention / Treatment: Drug: Dexmedetomidine Injection [Precedex]; Drug: Fentanyl HCl

Detailed Description

Acute appendicitis is among the most common causes of lower abdominal pain leading patients to attend the emergency department and the most common diagnosis made in young patients admitted to the hospital with an acute abdomen .

In intracavitary abdominal surgery (e.g. Appendectomy),general anesthesia is conventionally chosen as it provides a higher safety profile with respect to the risk of aspiration, abdominal discomfort, and better exposure secondary to muscle relaxation however, at present it is considered safe to do spinal anesthesia in various abdominal procedures, even where significant muscle relaxation is required in certain complex cases such as peritonitis many patients with complicated conditions were operated under spinal anesthesia, which did not significantly interfere with surgical technique or exposure. Additional advantages of spinal anesthesia include faster recovery, better oral tolerance, and shorter hospital stay compared to general anesthesia.

The Covid-19 pandemic currently affects almost every aspect of healthcare. The risk to the operating room team from the contaminated aerosols produced by intubation and positive pressure ventilation may be reduced by performing suitable open operations with neuraxial anaesthesia instead of General anesthesia .

Neuroaxial anesthesia is commonly preferred for surgeries of lower abdomen, perineal and lower limb. It is easy to administer and very economical but needs skills. Intrathecal local anesthetics are limited by short duration of action and needs early use of rescue analgesia postoperatively. Adjuvants are added to improve quality and duration, provide better postoperative analgesia and patient comfort.

A common problem during abdominal surgeries under spinal anesthesia is peritoneal related symptoms as visceral pain, nausea, vomiting, vagal symptoms like bradycardia and hypotension.

Many adjuvants like fentanyl, morphine, ketamine, neostigmine, and clonidine are being used to prolong the analgesic effects of local anaesthetic for many years. These drugs including opioids are usually results in several side effects include itching, decrease respiratory rate, difficulty in urination, postoperative gastrointestinal disturbance which can be overcome by preferring them as adjuvant with other analgesics.

Intraoperative peritoneal related symptoms as visceral pain, nausea, vomiting, vagal symptoms like bradycardia and hypotension are a common problem and there are some intrathecal adjuvants can solve these symptoms.

Fentanyl is µ receptor agonist 80 times more potent than morphine as an analgesic added to spinal 0.5% heavy bupivacaine improves quality of spinal analgesia, reduces visceral and somatic pain. However, their addition may have side effects like pruritus, respiratory depression, urinary retention, postoperative nausea and vomiting which limits their use.

Dexmedetomidine is highly selective α2-agonist, S-enantiomer of veterinary sedative medetomidine. Food and Drug Administration has approved its use for short-term ICU sedation, it is reported to provide sedation that parallels natural sleep, anxiolysis, analgesia, sympatholytic, and anaesthetic-sparing effect with minimal respiratory depression. α2- agonists produce clinical effects.

It was reported in a previous study that intraoperative dexmedetomidine can reduce the incidence of postoperative nausea and vomiting (PONV)in patients undergoing thoracic surgery and a dose-response relationship between intraoperative dexmedetomidine and PONV was Observed; and the optimal dose range for antiemetic effects of PONV is 50-100 μg. Previous small Some meta-analyses demonstrated that intraoperative dexmedetomidine significantly lowered post-operative pain scores and opioid consumption, which could lead to a reduced opioid-related adverse events, including PONV.

Dexmedetomidine prevents and reduces peritoneal related symptoms Intraoperative, and it can significantly lower the demand for opioids and inhalation anesthesia during and after operation, which could help to reduce opioid-related adverse events, including PONV.

• Study Type: Interventional
• Enrollment (Estimated): 148
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Soudy S Hammad, MD; Phone Number: +201014761523; Email: soudi.salah@aswu.edu.eg
• Study Contact Backup: Name: Ahmed M Hagag, MSc; Phone Number: 01141097536

Study Locations

• Egypt
  • Aswan, Egypt, 81528
    • Recruiting
    • Aswan University
    • Contact: Soudy S Hammad, MD; Phone Number: +201014761523; Email: soudi.salah@aswu.edu.eg
    • Contact: Ahmed M Hagag, MSc; Phone Number: 01141097536
    • Contact: Ayman M Eldemrdash, MD
    • Contact: Ahmed A Mahmoud, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. ASA grade III and IV.
2. Infection at the site of injection.
3. Coagulopathy or anticoagulation.
4. Congenital anomalies of lower spine.
5. Active disease of CNS.
6. History of allergy to local anesthetics or the adjuvants.
7. Complicated appendicitis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group D (N.74); 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]; 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.
Active Comparator: Group F (N.74) -; 25 µg Fentanyl {fentanyl Hameln 50 u/ml Gmbh-germany} + 4ml 0.5% heavy bupivacaine HCl.	Drug: Fentanyl HCl; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of motor block with Modified Bromage scale	Assessment of motor block with Modified Bromage scale; Bromage Scale: Bromage 0 - patient can move the hip, knee, and ankle.; Bromage 1 - patient is unable to move the hip but can move the knee and ankle.; Bromage 2 - patient is unable to move the hip and knee but able to move the ankle.Onset of Bromage 3 (min), Regression to bromage 0 (min). Bromage Scale: Bromage 0 - patient can move the hip, knee, and ankle.; Bromage 1 - patient is unable to move the hip but can move the knee and ankle.; Bromage 2 - patient is unable to move the hip and knee but able to move the ankle.	1,6,12,18 and 24 hours
Degree of post-operative analgesia	VI. The postoperative 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 1,6,12,18 and 24 hours (T1, T6, T12,T18 and T24) in the postoperative period	1,6,12,18 and 24 hours
Assessment of sensory block by using pin prick method	Assessment of sensory block by using pin prick method; Time from injection to T10(min) and Time from injection to highest Sensory cephalad spread, Resolution to T10 (min)	Time in minutes

Collaborators and Investigators

• Sponsor: Aswan University
• Investigators: Principal Investigator: Ayman M Eldemrdash, MD, Aswan University; Principal Investigator: Ahmed A Mahmoud, MD, Aswan University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): July 1, 2024
• Study Completion (Estimated): February 25, 2025

Study Registration Dates

• First Submitted: April 4, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 20, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Appendectomy; Peritoneal symptoms; Spinal ansthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Analgesics, Opioid; Narcotics; Neurotransmitter Agents; Adjuvants, Anesthesia; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Dexmedetomidine; Fentanyl
• Other Study ID Numbers: Asw.U./823 /7/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No