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DexmedetomidinePhase 3NCT06386783

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

A Phase 3 study testing Dexmedetomidine Injection [Precedex] and Fentanyl HCl in people with Dexmedetomidine and Fentanyl, run by Aswan University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Dexmedetomidine, Fentanyl
What is being tested?
Dexmedetomidine Injection [Precedex] and Fentanyl HCl
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
148 participants
Where
1 siteEgypt
Study dates
1 Jul 2023to 25 Feb 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Soudy S Hammad, MD contact

+201014761523

soudi.salah@aswu.edu.eg

Ahmed M Hagag, MSc contact

01141097536

Egypt1 site, 1 recruiting
  • Aswan University

    Aswān, Aswan Governorate, 81528

    Soudy S Hammad, MD, +201014761523, soudi.salah@aswu.edu.eg

    Ahmed M Hagag, MSc, 01141097536

    Recruiting

Other trials in Egypt

About this study

Official title: 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.

Read the 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.

Being tested
Dexmedetomidine Injection [Precedex], Fentanyl HCl
Keywords
Peritoneal symptoms, Spinal ansthesia, Appendectomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • Fentanyl HClDrug

    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.

Study groups in NCT06386783
Study groupRoleWhat they receive
Group D (N.74)Active comparator5µg 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.
Receives: Drug: Dexmedetomidine Injection [Precedex]
Group F (N.74) -Active comparator25 µg Fentanyl {fentanyl Hameln 50 u/ml Gmbh-germany} + 4ml 0.5% heavy bupivacaine HCl.
Receives: Drug: Fentanyl HCl

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Intraoperative period in minutes

Secondary outcomes (3)
  1. Assessment of motor block with Modified Bromage scale

    Assessment of motor block with Modified Bromage scale;

    Bromage Scale:

    1. Bromage 0 - patient can move the hip, knee, and ankle.
    2. Bromage 1 - patient is unable to move the hip but can move the knee and ankle.
    3. 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:

    1. Bromage 0 - patient can move the hip, knee, and ankle.
    2. Bromage 1 - patient is unable to move the hip but can move the knee and ankle.
    3. Bromage 2 - patient is unable to move the hip and knee but able to move the ankle.

    Measured: 1,6,12,18 and 24 hours

  2. 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

    Measured: 1,6,12,18 and 24 hours

  3. 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)

    Measured: Time in minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2024
  2. Study start1 Jul 2023
  3. Primary completion1 Jul 2024
  4. Study completion25 Feb 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This randomized double blinded study will be conducted at Aswan university hospitals at patients scheduled for emergency appendectomy
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
148 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06386783
Sponsor's protocol ID
Asw.U./823 /7/23
Status last verified
May 2024
First submitted
4 Apr 2024
Last updated
21 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 31363392
  • 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.

    PubMed 21897504

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dexmedetomidine Injection [Precedex] and Fentanyl HCl in people with Dexmedetomidine and Fentanyl, run by Aswan University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Soudy S Hammad, MD (+201014761523, soudi.salah@aswu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

intraoperative peritoneal symptoms during appendectomy. (time frame: Intraoperative period in minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06386783, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.

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