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.
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.
Ahmed M Hagag, MSc contact
Egypt1 site, 1 recruiting
- Recruiting
Aswan University
Aswān, Aswan Governorate, 81528
Soudy S Hammad, MD, +201014761523, soudi.salah@aswu.edu.eg
Ahmed M Hagag, MSc, 01141097536
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.
- Conditions
- Dexmedetomidine, Fentanyl
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Fentanyl HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
Measured: 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
Measured: 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)
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.
- First posted26 Apr 2024
- Study start1 Jul 2023
- Primary completion1 Jul 2024
- Study completion25 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DexmedetomidineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Aswan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soudy Salah Hammad, Aswan University
- Investigators
- Ayman M Eldemrdash, MD, Principal investigator, Aswan UniversityAhmed A Mahmoud, MD, Principal investigator, Aswan University
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 31363392Gupta 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fentanyl Versus Dexmedetomidine as an Adjuvant to Bupivacaine in Spinal Anaesthesia for Appendectomy Patients; Peritoneal Symptomatic Effects: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06386783
- Acronym / sponsor ID
- Asw.U./823 /7/23
- Conditions
- Dexmedetomidine, Fentanyl
- Keywords
- Peritoneal symptoms, Spinal ansthesia, Appendectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Aswan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 25 Feb 2025 (estimated)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This randomized double blinded study will be conducted at Aswan university hospitals at patients scheduled for emergency appendectomy
| Arm | Type | Receives |
|---|---|---|
| Group D (N.74) | Active comparator | Drug: Dexmedetomidine Injection [Precedex]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. |
| Group F (N.74) - | Active comparator | Drug: Fentanyl HCl25 µg Fentanyl {fentanyl Hameln 50 u/ml Gmbh-germany} + 4ml 0.5% heavy bupivacaine HCl. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA physical status class I and II.
- Age between 18 - 60 years of either sex.
Key exclusion criteria (7 listed)
- ASA grade III and IV.
- Infection at the site of injection.
- Coagulopathy or anticoagulation.
- Congenital anomalies of lower spine.
- Active disease of CNS.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Group D (N.74) |
| Fentanyl HClCompare 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. | Drug | Group F (N.74) - |
Primary outcome
intraoperative peritoneal symptoms during appendectomy.
Time frame: Intraoperative period in minutes
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.
3 secondary outcomes
Assessment of motor block with Modified Bromage scale
Time frame: 1,6,12,18 and 24 hours
Degree of post-operative analgesia
Time frame: 1,6,12,18 and 24 hours
Assessment of sensory block by using pin prick method
Time frame: Time in minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Background: PubMed 31363392Minagar 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.
- Background: PubMed 21897504Gupta 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed M Hagag, MSc contact
Ayman M Eldemrdash, MD principal investigator
Aswan University
Ahmed A Mahmoud, MD principal investigator
Aswan University
1 site in 1 country: see every site and its status.
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.