- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06628648
Hypertension as a Reason for Concellation of Elective Minor Abdominal Surgery
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.
Study Overview
Status
Conditions
Detailed Description
During the anesthesia outpatient consultation, patients proposed for minor abdominal surgery, known hypertensive patients are selected. If the blood pressure figures are balanced in the previous 12 months, they are included in the study and the anesthesiologist informs them of the study protocol and obtains their consent.
On the day of the procedure, the patient is admitted to the operating room. We begin warming the patient and carry out standard monitoring, then, 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Nabeul, Tunisia, 8000
- HIBET ALLAH ktata
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients aged 18 or over, consenting
- known hypertensive patients.
- Patients proposed for planned minor abdominal surgery (≤ 2 hours).
Exclusion Criteria:
- patients not premedicated (antihypertensive treatment)
Non-inclusion criteria:
- patient refusal .history of hypertensive emergency within 06 months.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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canceled
Hypertensive patients proposed for minor abdominal surgery and canceled for high blood pressure numbers.
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not canceled
Hypertensive patients proposed for minor abdominal surgery not canceled: whose blood pressure figures are correct.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Incidence of surgery canceled due to high blood pressure figures in the operating room.
Time Frame: In the operating room
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In the operating room, if the blood pressure figures are high(according to BHS recommendations from 2016) the surgery is canceled
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In the operating room
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Score d'anxiété: Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Time Frame: before entering the operating room
|
The APAIS scale is presented in the form of a questionnaire composed of six questions, the first three of which assess the patient's anxiety relating to anesthesia, the following two assess the patient's anxiety relating to surgery, and finally a last question assesses the patient's desire for information. The minimum score is 6 and the maximum is 20. If the score is greater than 11, this means that the patient's level of anxiety is high |
before entering the operating room
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The quality of reception in the operating room
Time Frame: before entering the operating room
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Patient satisfaction: Bad/average/good
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before entering the operating room
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History of cancellation for hypertension in the operating room
Time Frame: Pre-operative, at the anesthesia consultation
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presence or absence of a history of cancellation for high blood pressure figures
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Pre-operative, at the anesthesia consultation
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specify the anti-hypertension molecule
Time Frame: Pre-operative, at the anesthesia consultation
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the antihypertensive molecule taken by the patient as background treatment
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Pre-operative, at the anesthesia consultation
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Control and monitoring of hypertension Control and monitoring of hypertension Control and monitoring of hypertension
Time Frame: During the pre-anesthesia consultation
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The patient is followed-up in town: by a general practitioner or a cardiologist
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During the pre-anesthesia consultation
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Entrance to the operating room: on foot, chair or trolley
Time Frame: before entering the operating room
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Arrival at the operating room: on foot, chair or trolley
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before entering the operating room
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Day of the week
Time Frame: before entering the operating room
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Day of the week: from Monday to Saturday
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before entering the operating room
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Waiting time before entering the operating room (in minutes)
Time Frame: before entering the operating room
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waiting time before entering the operating room: in minutes
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before entering the operating room
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: BENALI MECHAAL, Professor, maamouri nabeul
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UTEM HCS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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