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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.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

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

Other trials in Egypt

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:

  1. Patients scheduled for abdominal aortic surgery under general anesthesia
  2. American Society of Anesthesiologists ASA I-III.
  3. aged 20-60

Exclusion criteria:

  1. Patients with a history of previous abdominal surgery.
  2. uncontrolled hypertension or diabetes, major cardiopulmonary disease.
  3. 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).
  4. allergy to study drugs
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 groups in NCT05577260
Study groupRoleWhat they receive
Group D(dexemedetomidine group)ExperimentalPatients 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)ExperimentalPatients 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.

  1. time for first anelgesic request

    first postoperative time patients request anelgesia

    Measured: 24 hours postoperative

Secondary outcomes (1)
  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.

  1. First posted13 Oct 2022
  2. Study start1 Oct 2022
  3. Primary completion1 Jan 2023 (estimated)
  4. Study completion15 Jan 2023 (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 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)
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

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.

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