Hypertension SecondaryNCT06628648
Hypertension as a Reason for Concellation of Elective Minor Abdominal Surgery
An observational study of Hypertension Secondary and Surgery, run by University Tunis El Manar at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hypertension Secondary, Surgery
- How many people
- 120 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Apr 2024to 20 Jan 2026
- Phase
- Observational
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients aged 18 or over, consenting
- known hypertensive patients.
- Patients proposed for planned minor abdominal surgery (≤ 2 hours).
Who cannot join
- patients not premedicated (antihypertensive treatment)
- Non-inclusion criteria:
- patient refusal .history of hypertensive emergency within 06 months.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hypertension Secondary, Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: In the operating room
Secondary outcomes (8)
Score d'anxiété: Amsterdam Preoperative Anxiety and Information Scale (APAIS)
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
Measured: before entering the operating room
The quality of reception in the operating room
Patient satisfaction: Bad/average/good
Measured: before entering the operating room
History of cancellation for hypertension in the operating room
presence or absence of a history of cancellation for high blood pressure figures
Measured: Pre-operative, at the anesthesia consultation
specify the anti-hypertension molecule
the antihypertensive molecule taken by the patient as background treatment
Measured: Pre-operative, at the anesthesia consultation
Control and monitoring of hypertension Control and monitoring of hypertension Control and monitoring of hypertension
The patient is followed-up in town: by a general practitioner or a cardiologist
Measured: During the pre-anesthesia consultation
Entrance to the operating room: on foot, chair or trolley
Arrival at the operating room: on foot, chair or trolley
Measured: before entering the operating room
Day of the week
Day of the week: from Monday to Saturday
Measured: before entering the operating room
Waiting time before entering the operating room (in minutes)
waiting time before entering the operating room: in minutes
Measured: before entering the operating room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Apr 2024
- Primary completion15 Dec 2025
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension SecondaryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HibetAllah Ktata, University Tunis El Manar
- Investigators
- BENALI MECHAAL, Professor, Principal investigator, maamouri nabeul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628648
- Sponsor's protocol ID
- UTEM HCS
- Status last verified
- Jan 2026
- First submitted
- 30 Sep 2024
- Last updated
- 2 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypertension as a Reason for Concellation of Elective Minor Abdominal Surgery
- ClinicalTrials.gov ID
- NCT06628648
- Acronym / sponsor ID
- UTEM HCS
- Conditions
- Hypertension Secondary, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 8 Oct 2024 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- patients aged 18 or over, consenting
- known hypertensive patients.
- Patients proposed for planned minor abdominal surgery (≤ 2 hours).
Key exclusion criteria (3 listed)
- patients not premedicated (antihypertensive treatment)
- patient refusal .history of hypertensive emergency within 06 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of surgery canceled due to high blood pressure figures in the operating room.
Time frame: 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
8 secondary outcomes
Score d'anxiété: Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Time frame: before entering the operating room
The quality of reception in the operating room
Time frame: before entering the operating room
History of cancellation for hypertension in the operating room
Time frame: Pre-operative, at the anesthesia consultation
specify the anti-hypertension molecule
Time frame: Pre-operative, at the anesthesia consultation
Control and monitoring of hypertension Control and monitoring of hypertension Control and monitoring of hypertension
Time frame: During the pre-anesthesia consultation
Entrance to the operating room: on foot, chair or trolley
Time frame: before entering the operating room
Day of the week
Time frame: before entering the operating room
Waiting time before entering the operating room (in minutes)
Time frame: before entering the operating room
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
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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.
BENALI MECHAAL, Professor principal investigator
maamouri nabeul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension Secondary and Surgery, run by University Tunis El Manar at 1 site in Tunisia.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 2 Feb 2026. 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 Tunisia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of surgery canceled due to high blood pressure figures in the operating room. (time frame: In the operating room). 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 2 Feb 2026.