NCT06628648

Brief Summary

During the anesthesia outpatient consultation, patients proposed for minor abdominal surgery, known hypertensive patients are selected. On the day of the procedure, we check the blood pressure figures. If the numbers are high: SBP ≥ 180 and/or PAD≥110: we start by a filling as well as a dose of 1 mg Midazolam IV and the blood pressure figures are re-evaluated. If 3 measurements blood pressure figures remain above the threshold values: Surgery is postponed and the patient will be included to group (A) for canceled. If the blood pressure figures are correct, the surgery is accepted and the patient will be included in the group (NA) for not canceled.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2026

Completed
Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

1.7 years

First QC Date

September 30, 2024

Last Update Submit

January 30, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of surgery canceled due to high blood pressure figures in the operating room.

    In the operating room, if the blood pressure figures are high(according to BHS recommendations from 2016) the surgery is canceled

    In the operating room

Secondary Outcomes (8)

  • Score d'anxiété: Amsterdam Preoperative Anxiety and Information Scale (APAIS)

    before entering the operating room

  • The quality of reception in the operating room

    before entering the operating room

  • History of cancellation for hypertension in the operating room

    Pre-operative, at the anesthesia consultation

  • specify the anti-hypertension molecule

    Pre-operative, at the anesthesia consultation

  • Control and monitoring of hypertension Control and monitoring of hypertension Control and monitoring of hypertension

    During the pre-anesthesia consultation

  • +3 more secondary outcomes

Study Arms (2)

canceled

Hypertensive patients proposed for minor abdominal surgery and canceled for high blood pressure numbers.

not canceled

Hypertensive patients proposed for minor abdominal surgery not canceled: whose blood pressure figures are correct.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients included for this study: proposed for minor abdominal surgery, known hypertensive, prepared for the surgical procedure. Patient recruitment will be carried out over a period of 7 months by the anesthesia team with cooperation from the general surgery team.

You may qualify if:

  • patients aged 18 or over, consenting
  • known hypertensive patients.
  • Patients proposed for planned minor abdominal surgery (≤ 2 hours).

You may not qualify if:

  • patients not premedicated (antihypertensive treatment)
  • patient refusal .history of hypertensive emergency within 06 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HIBET ALLAH ktata

Nabeul, 8000, Tunisia

Location

Study Officials

  • BENALI MECHAAL, Professor

    maamouri nabeul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate Professor

Study Record Dates

First Submitted

September 30, 2024

First Posted

October 8, 2024

Study Start

April 1, 2024

Primary Completion

December 15, 2025

Study Completion

January 20, 2026

Last Updated

February 2, 2026

Record last verified: 2026-01

Locations