Abdominal Aortic SurgeryNCT05577260
The Effect of Intraperitoneal Injection of Magnesium Sulphate Versus Dexmedetomidine as an Adjuvant to Bupivacaine on Postoperative Analgesia in Patients Undergoing Abdominal Aortic Surgery
A study testing magnesuim sulphate, Dexmedetomidine and isobaric bupivacaine in people with Abdominal Aortic Surgery, run by Mansoura University at 1 site in Egypt.
Trial summary
optimal management of postoperative pain is essentiel for better outcome in abdominal aortic surgery.the study aim to compare between analgesic effect of magnesium sulphate versus dexmedetomidine as an adjuvant to bupivacaine when injected intraperitoneal in abdominal aortic surgery.METHODS:50 patients undergoing… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Abdominal Aortic Surgery
- What is being tested?
- magnesuim sulphate, Dexmedetomidine and isobaric bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 15 Jan 2023
- Phase
- Interventional
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients scheduled for abdominal aortic surgery under general anesthesia
- American Society of Anesthesiologists ASA I-III.
Who cannot join
- Patients with a history of previous abdominal surgery.
- uncontrolled hypertension or diabetes, major cardiopulmonary disease.
- psychiatric illness .
- allergy to study drugs
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University,Mansoura University Hospitals
Al Mansurah, Dakahlia Governorate, 35516
About this study
optimal management of postoperative pain is essentiel for better outcome in abdominal aortic surgery.the study aim to compare between analgesic effect of magnesium sulphate versus dexmedetomidine as an adjuvant to bupivacaine when injected intraperitoneal in abdominal aortic surgery.METHODS:50 patients undergoing abdominal aortic surgery are randemelly divided into 2 groups.(group D:patients received 20ml isobaric bupivacaine+1mic/kg dexemedetomidine completed to 5ml normal saline) Group M:patients received 20ml isobaric bupivacaine+5mg magnesuim sulphate .postoperative VAS,MAP will be recorded initially then every 2hours.
Read the detailed description
AIM OF THE study To compare between analgesic effect of magnesium sulphate versus dexmedetomidine as an adjuvant to bupivacaine when injected intraperitoneal in abdominal aortic surgery methods This study conducted on patients scheduled for abdominal aortic surgery under general anesthesia in Mansoura University Hospitals .The duration of the study is approximately 5 months. The operation will be done after informed written consent from all patients.
Inclusion criteria:
- Patients scheduled for abdominal aortic surgery under general anesthesia
- American Society of Anesthesiologists ASA I-III.
- aged 20-60
Exclusion criteria:
- Patients with a history of previous abdominal surgery.
- uncontrolled hypertension or diabetes, major cardiopulmonary disease.
- psychiatric illness . On the operation day, the patients will be transferred to the operative theater, where a peripheral cannula will be inserted in a suitable forearm vein. All patients received IV midazolam 5 mg to decrease their anxiety. Routine hemodynamic monitoring will be connected, including ECG, pulse oximetry, heart rate, and noninvasive blood pressure. We will induce general anesthesia by IV propofol 1-2 mg.kg-1, fentanyl 1 μg.kg-1, in addition to atracurium 0.5 mg.kg-1. Sevoflurane inhalation was used to maintain anesthesia at a minimal alveolar concentration of 2%. Continuous monitoring of hemodynamics was done throughout the procedure. Heart rate and mean arterial pressure (MAP) were recorded at baseline, then every 15 minutes till the operation ended. Hypotension, defined as systolic blood pressure decreased by 20% or more of its baseline value , was managed by crystalloid infusion (5 ml.kg-1) and IV ephedrine (0.1 mg.kg-1). Additionally, bradycardia, defined as heart rate below 50 bpm , was managed by IV atropine (0.2 - 0.5 mg). Tested drugs will be prepared in a sterile syringe by the hospital pharmacy and given to the aneasthetist who was blinded to the identity of drugs. After hemostasis was achieved, intraperitoneal instillation of the drugs into the peritoneal cavity by the surgeon. After the operation, patients will be transferred to the PACU, then to the internal ward, where close monitoring and assessment will be done. MAP and heart rates were also recorded every 15 minutes for two hours after surgery. They will be instructed to express their pain via the visual analogue score (VAS), with zero for no pain and ten for the maximum pain sensation ever experienced. These readings will be recorded at PACU, then every two hours for the initial 12 hours after surgery, and finally at 16 and 24 hours. If the patient reported a VAS of four or more, IV fentanyl 20-30 μg commenced. The total post-operative opioid consumption was calculated and recorded. Any opioid-related adverse events, including respiratory depression, nausea, and vomiting, were noticed and recorded. The latter two complaints will be managed by IV metoclopramide (10 mg).
- allergy to study drugs
- Conditions
- Abdominal Aortic Surgery
- Being tested
- magnesuim sulphate, Dexmedetomidine, isobaric bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnesuim sulphateDrug
magnesuim sulphate
DexmedetomidineDrug
Dexmedetomidine
isobaric bupivacaineDrug
20ml isobaric bupivacaine 0.25%
| Study group | Role | What they receive |
|---|---|---|
| Group D(dexemedetomidine group) | Experimental | Patients receive 20 mL isobaric bupivacaine 0.25% + 1μg/kg Dexmedetomidine completed to 5ml with normal saline. Receives: Drug: Dexmedetomidine; Drug: isobaric bupivacaine |
| Group M: (magnesuim sulphate group) | Experimental | Patients received 20ml isobaric bupivacaine 0.25% + 5 ml (500 mg) magnesium sulphate Receives: Drug: magnesuim sulphate; Drug: isobaric bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
time for first anelgesic request
first postoperative time patients request anelgesia
Measured: 24 hours postoperative
Secondary outcomes (1)
total anelgesic requirement
total dose of anelgesia given to the patients postoperative
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start1 Oct 2022
- Primary completion1 Jan 2023 (estimated)
- Study completion15 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic SurgeryStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ghada fouad, Mansoura University
- Investigators
- GHADA f amer, MD, Principal investigator, Associate Professor OFanesthesia Mansoura university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577260
- Sponsor's protocol ID
- -MFM-IRB .R.22.08.1784
- Status last verified
- Oct 2022
- First submitted
- 10 Oct 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraperitoneal Injection of Magnesium Sulphate Versus Dexmedetomidine as an Adjuvant to Bupivacaine on Postoperative Analgesia in Patients Undergoing Abdominal Aortic Surgery
- ClinicalTrials.gov ID
- NCT05577260
- Acronym / sponsor ID
- -MFM-IRB .R.22.08.1784
- Conditions
- Abdominal Aortic Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 15 Jan 2023 (estimated)
- First posted
- 13 Oct 2022 (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.
optimal management of postoperative pain is essentiel for better outcome in abdominal aortic surgery.the study aim to compare between analgesic effect of magnesium sulphate versus dexmedetomidine as an adjuvant to bupivacaine when injected intraperitoneal in abdominal aortic surgery.METHODS:50 patients undergoing abdominal aortic surgery are randemelly divided into 2 groups.(group D:patients received 20ml isobaric bupivacaine+1mic/kg dexemedetomidine completed to 5ml normal saline) Group M:patients received 20ml isobaric bupivacaine+5mg magnesuim sulphate .postoperative VAS,MAP will be recorded initially then every 2hours.
Detailed description
AIM OF THE study To compare between analgesic effect of magnesium sulphate versus dexmedetomidine as an adjuvant to bupivacaine when injected intraperitoneal in abdominal aortic surgery methods This study conducted on patients scheduled for abdominal aortic surgery under general anesthesia in Mansoura University Hospitals .The duration of the study is approximately 5 months. The operation will be done after informed written consent from all patients.
Inclusion criteria:
- Patients scheduled for abdominal aortic surgery under general anesthesia
- American Society of Anesthesiologists ASA I-III.
- aged 20-60
Exclusion criteria:
- Patients with a history of previous abdominal surgery.
- uncontrolled hypertension or diabetes, major cardiopulmonary disease.
- psychiatric illness . On the operation day, the patients will be transferred to the operative theater, where a peripheral cannula will be inserted in a suitable forearm vein. All patients received IV midazolam 5 mg to decrease their anxiety. Routine hemodynamic monitoring will be connected, including ECG, pulse oximetry, heart rate, and noninvasive blood pressure. We will induce general anesthesia by IV propofol 1-2 mg.kg-1, fentanyl 1 μg.kg-1, in addition to atracurium 0.5 mg.kg-1. Sevoflurane inhalation was used to maintain anesthesia at a minimal alveolar concentration of 2%. Continuous monitoring of hemodynamics was done throughout the procedure. Heart rate and mean arterial pressure (MAP) were recorded at baseline, then every 15 minutes till the operation ended. Hypotension, defined as systolic blood pressure decreased by 20% or more of its baseline value , was managed by crystalloid infusion (5 ml.kg-1) and IV ephedrine (0.1 mg.kg-1). Additionally, bradycardia, defined as heart rate below 50 bpm , was managed by IV atropine (0.2 - 0.5 mg). Tested drugs will be prepared in a sterile syringe by the hospital pharmacy and given to the aneasthetist who was blinded to the identity of drugs. After hemostasis was achieved, intraperitoneal instillation of the drugs into the peritoneal cavity by the surgeon. After the operation, patients will be transferred to the PACU, then to the internal ward, where close monitoring and assessment will be done. MAP and heart rates were also recorded every 15 minutes for two hours after surgery. They will be instructed to express their pain via the visual analogue score (VAS), with zero for no pain and ten for the maximum pain sensation ever experienced. These readings will be recorded at PACU, then every two hours for the initial 12 hours after surgery, and finally at 16 and 24 hours. If the patient reported a VAS of four or more, IV fentanyl 20-30 μg commenced. The total post-operative opioid consumption was calculated and recorded. Any opioid-related adverse events, including respiratory depression, nausea, and vomiting, were noticed and recorded. The latter two complaints will be managed by IV metoclopramide (10 mg).
- allergy to study drugs
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group D(dexemedetomidine group) | Experimental | Drug: Dexmedetomidine, Drug: isobaric bupivacainePatients receive 20 mL isobaric bupivacaine 0.25% + 1μg/kg Dexmedetomidine completed to 5ml with normal saline. |
| Group M: (magnesuim sulphate group) | Experimental | Drug: magnesuim sulphate, Drug: isobaric bupivacainePatients received 20ml isobaric bupivacaine 0.25% + 5 ml (500 mg) magnesium sulphate |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients scheduled for abdominal aortic surgery under general anesthesia
- American Society of Anesthesiologists ASA I-III.
Key exclusion criteria (4 listed)
- Patients with a history of previous abdominal surgery.
- uncontrolled hypertension or diabetes, major cardiopulmonary disease.
- psychiatric illness .
- allergy to study drugs
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 |
|---|---|---|
| magnesuim sulphatemagnesuim sulphate | Drug | Group M: (magnesuim sulphate group) |
| DexmedetomidineDexmedetomidine | Drug | Group D(dexemedetomidine group) |
| isobaric bupivacaine20ml isobaric bupivacaine 0.25% | Drug | Group D(dexemedetomidine group), Group M: (magnesuim sulphate group) |
Primary outcome
time for first anelgesic request
Time frame: 24 hours postoperative
first postoperative time patients request anelgesia
1 secondary outcome
total anelgesic requirement
Time frame: 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Individual participant dataSharing planned: Yes
Related trials for Abdominal Aortic Surgery
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Not yet recruitingObservational study
Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection
Recruiting
The Hypotension Prediction Index Versus Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic Surgery
Elective Endovascular Abdominal Aortic Surgery With an Expected Surgical Duration Exceeding 2 Hours, Elective Open Abdominal Aortic Surgery With an Expected Surgical Duration Exceeding 2 Hours
RecruitingObservational study
Patient-Reported Quality of Life After Open Surgery for Complex Abdominal Aortic Aneurysms: A Prospective Study
Complex Abdominal Aortic Aneurysms
Not yet recruitingObservational study
Deep-learning Predictors of Abdominal Aortic Aneurysm Enlargement in Type II Endoleaks After Endovascular Aortic Repair: The RADAR Study
Type II Endoleak, Abdominal Aortic Aneurysm Enlargement
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.
GHADA f amer, MD principal investigator
Associate Professor OFanesthesia Mansoura university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing magnesuim sulphate, Dexmedetomidine and isobaric bupivacaine in people with Abdominal Aortic Surgery, run by Mansoura 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 4 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 13 Oct 2022. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time for first anelgesic request (time frame: 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2022.