NCT05577260

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2023

Completed
Last Updated

October 13, 2022

Status Verified

October 1, 2022

Enrollment Period

3 months

First QC Date

October 10, 2022

Last Update Submit

October 11, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • time for first anelgesic request

    first postoperative time patients request anelgesia

    24 hours postoperative

Secondary Outcomes (1)

  • total anelgesic requirement

    24 hours postoperative

Study Arms (2)

Group D(dexemedetomidine group)

EXPERIMENTAL

Patients receive 20 mL isobaric bupivacaine 0.25% + 1μg/kg Dexmedetomidine completed to 5ml with normal saline.

Drug: DexmedetomidineDrug: isobaric bupivacaine

Group M: (magnesuim sulphate group)

EXPERIMENTAL

Patients received 20ml isobaric bupivacaine 0.25% + 5 ml (500 mg) magnesium sulphate

Drug: magnesuim sulphateDrug: isobaric bupivacaine

Interventions

magnesuim sulphate

Group M: (magnesuim sulphate group)

Dexmedetomidine

Group D(dexemedetomidine group)

20ml isobaric bupivacaine 0.25%

Group D(dexemedetomidine group)Group M: (magnesuim sulphate group)

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients scheduled for abdominal aortic surgery under general anesthesia
  • American Society of Anesthesiologists ASA I-III.

You may not qualify if:

  • Patients with a history of previous abdominal surgery.
  • uncontrolled hypertension or diabetes, major cardiopulmonary disease.
  • psychiatric illness .
  • allergy to study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University,Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • GHADA f amer, MD

    Associate Professor OFanesthesia Mansoura university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor of anesthesia

Study Record Dates

First Submitted

October 10, 2022

First Posted

October 13, 2022

Study Start

October 1, 2022

Primary Completion

January 1, 2023

Study Completion

January 15, 2023

Last Updated

October 13, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

Locations