Controlled Hypotension for Nasal SurgeriesNCT07460050
Comparison of Two Sedative Agents in Terms of Controlled Hypotension
A study testing Propofol and Isoflurane in people with Controlled Hypotension for Nasal Surgeries, run by Hayatabad Medical Complex at 1 site in Pakistan.
Trial summary
Propofol and Isoflurane are commonly used sedative agents in general anaesthesia.Both these drugs have a side effect of decreasing blood pressure which when used optimally can be used to acheive controlled hypotention. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Controlled Hypotension for Nasal Surgeries
- What is being tested?
- Propofol and Isoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2026to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Either male/female Age 18-65 Patients undergoing endoscopic sinus surgery as per the operational definition
Who cannot join
- Patients with cardiovascular disease Patients with pregnancy Patients with coagulopathy Patients on beta blockers or calcium channel blockers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Hayatabad Medical Complex, Peshawar
Peshawar, Khyber Pakhtunkhwa, 25000
Laiba Khalid, Trainee Medical Officer, 03320031941, kgmcite15@gmail.com
About this study
Official title: COMPARISON OF PROPOFOL INFUSION VS INHALATIONAL AGENT ISOFLURANE IN TERMS OF CONTROLLED HYPOTENSION IN PATIENTS UNDERGOING ENDOSCOPIC SINUS SURGERY
Propofol and Isoflurane are commonly used sedative agents in general anaesthesia.Both these drugs have a side effect of decreasing blood pressure which when used optimally can be used to acheive controlled hypotention. So, it provides a better visiblity of surgical filed to the surgeons.This RCT compares propofol infusion vs isoflurane inhalation for inducing controlled hypotension during endoscopic sinus surgery. The goal is to assess which agent better controls blood pressure, improves surgical field visibility, and impacts recovery. It likely measures outcomes like hemodynamics, bleeding, and surgeon satisfaction.
Read the detailed description
Propofol is a rapid-acting, intravenous sedative-hypnotic agent used for the induction and maintenance of general anesthesia, procedural sedation, and sedation for mechanically ventilated ICU patients. It acts by enhancing GABAergic inhibition in the brain, offering quick onset and short duration of action.
Isoflurane is a widely used halogenated ether inhalational agent for the induction and maintenance of general anesthesia functions as a central nervous system depressant by interacting with various receptors, including GABA, glutamate, and glycine receptors, to produce anesthesia. Both agents have side effect of hypotention which is useful during surgery for controlled hemodynamics, surgical field visibility and better recovery but evidence regarding their comparative effectiveness remains inconsistent. So i am comparing propofol infusion vs isoflurane for controlled hypotension in endoscopic sinus surgery. This randomized controlled trial will be conducted in the Department of Anaesthesiology, PGMI/ Hayatabad Medical Complex, Peshawar. A total of 136 adult patients with ASA physical status l -ll , scheduled for elective endoscopic sinus surgery under general anaesthesia will be enrolled and randomized into two equal groups. Group P will receive Propofol infusion at a dose starting at 12mg/kg/ hr titrated to the desire effect(target MAP 60-70 mmHg) while Group I will receive isoflurane inhalation (1-2% end-tidal, same MAP target). Outcomes like Surgical field quality , blood loss, recovery time, hemodynamic stability, side effects (shivering, nausea) will be observed and noted
- Being tested
- Propofol, Isoflurane
- Keywords
- Controlled hypotention, Propofol infusion, Endoscopic sinus surgery, Isoflurane inhalation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Intravenous propofol infusion (starting dose 12mg/kg/hr and titrated accordingly) given to patients as sedative undergoing endscopic sinus surgery for hemodynamic stability
IsofluraneDrug
Isoflurane inhalation (1-2% end tidal) used in patients as sedative undergoing endoscopic sinus surgery for hemodynamic stability
| Study group | Role | What they receive |
|---|---|---|
| Patient receiving Propofol infusion for controlled hypotention during surgery under general anaes | Experimental | Intravenous propfol infusion (starting 12mg/kg/hr) adminitration intraoperatively as sedative for controlled hypotension during endoscopic sinus surgery Receives: Drug: Propofol |
| Isoflurane inhalation for controlled hypotension during surgery under general anaesthesia | Active comparator | Isoflurane inhalation (1-2% end tidal) given intraoperativley as sedative for controlled hypotension during eendoscopic sinus surgery Receives: Drug: Isoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical field visibility
Measured: The surgical field visibility time frame for propofol vs isoflurane during endoscopic sinus surgery assessed intraoperatively is usually 30-60mins postinduction
Surgical field visibility
Measured: The surgical field visibility time frame assessed intraoperatively during endoscopic sinus surgery is usually 30- 60 mins post induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Controlled Hypotension for Nasal SurgeriesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hayatabad Medical Complex
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Amina Sultan, Hayatabad Medical Complex
- Investigators
- Dr. Laiba Khalid, Postgraduate trainee, Study chair, Hayat Abad Medical Complex, Peshawar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460050
- Sponsor's protocol ID
- ISO-PROP-01
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to patient confidentiality and institutional policies
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF PROPOFOL INFUSION VS INHALATIONAL AGENT ISOFLURANE IN TERMS OF CONTROLLED HYPOTENSION IN PATIENTS UNDERGOING ENDOSCOPIC SINUS SURGERY
- ClinicalTrials.gov ID
- NCT07460050
- Acronym / sponsor ID
- ISO-PROP-01
- Keywords
- Controlled hypotention, Propofol infusion, Endoscopic sinus surgery, Isoflurane inhalation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Hayatabad Medical ComplexOther government
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 10 Mar 2026 (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.
Propofol and Isoflurane are commonly used sedative agents in general anaesthesia.Both these drugs have a side effect of decreasing blood pressure which when used optimally can be used to acheive controlled hypotention. So, it provides a better visiblity of surgical filed to the surgeons.This RCT compares propofol infusion vs isoflurane inhalation for inducing controlled hypotension during endoscopic sinus surgery. The goal is to assess which agent better controls blood pressure, improves surgical field visibility, and impacts recovery. It likely measures outcomes like hemodynamics, bleeding, and surgeon satisfaction.
Detailed description
Propofol is a rapid-acting, intravenous sedative-hypnotic agent used for the induction and maintenance of general anesthesia, procedural sedation, and sedation for mechanically ventilated ICU patients. It acts by enhancing GABAergic inhibition in the brain, offering quick onset and short duration of action.
Isoflurane is a widely used halogenated ether inhalational agent for the induction and maintenance of general anesthesia functions as a central nervous system depressant by interacting with various receptors, including GABA, glutamate, and glycine receptors, to produce anesthesia. Both agents have side effect of hypotention which is useful during surgery for controlled hemodynamics, surgical field visibility and better recovery but evidence regarding their comparative effectiveness remains inconsistent. So i am comparing propofol infusion vs isoflurane for controlled hypotension in endoscopic sinus surgery. This randomized controlled trial will be conducted in the Department of Anaesthesiology, PGMI/ Hayatabad Medical Complex, Peshawar. A total of 136 adult patients with ASA physical status l -ll , scheduled for elective endoscopic sinus surgery under general anaesthesia will be enrolled and randomized into two equal groups. Group P will receive Propofol infusion at a dose starting at 12mg/kg/ hr titrated to the desire effect(target MAP 60-70 mmHg) while Group I will receive isoflurane inhalation (1-2% end-tidal, same MAP target). Outcomes like Surgical field quality , blood loss, recovery time, hemodynamic stability, side effects (shivering, nausea) will be observed and noted
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient receiving Propofol infusion for controlled hypotention during surgery under general anaes | Experimental | Drug: PropofolIntravenous propfol infusion (starting 12mg/kg/hr) adminitration intraoperatively as sedative for controlled hypotension during endoscopic sinus surgery |
| Isoflurane inhalation for controlled hypotension during surgery under general anaesthesia | Active comparator | Drug: IsofluraneIsoflurane inhalation (1-2% end tidal) given intraoperativley as sedative for controlled hypotension during eendoscopic sinus surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Either male/female Age 18-65 Patients undergoing endoscopic sinus surgery as per the operational definition
Key exclusion criteria (1 listed)
- Patients with cardiovascular disease Patients with pregnancy Patients with coagulopathy Patients on beta blockers or calcium channel blockers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolIntravenous propofol infusion (starting dose 12mg/kg/hr and titrated accordingly) given to patients as sedative undergoing endscopic sinus surgery for hemodynamic stability | Drug | Patient receiving Propofol infusion for controlled hypotention during surgery under general anaes |
| IsofluraneIsoflurane inhalation (1-2% end tidal) used in patients as sedative undergoing endoscopic sinus surgery for hemodynamic stability | Drug | Isoflurane inhalation for controlled hypotension during surgery under general anaesthesia |
Primary outcome
Surgical field visibility
Time frame: The surgical field visibility time frame for propofol vs isoflurane during endoscopic sinus surgery assessed intraoperatively is usually 30-60mins postinduction
Surgical field visibility
Time frame: The surgical field visibility time frame assessed intraoperatively during endoscopic sinus surgery is usually 30- 60 mins post induction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to patient confidentiality and institutional policies
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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.
Dr. Laiba Khalid, Postgraduate trainee study chair
Hayat Abad Medical Complex, Peshawar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol and Isoflurane in people with Controlled Hypotension for Nasal Surgeries, run by Hayatabad Medical Complex at 1 site in Pakistan.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 10 Mar 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Laiba Khalid, Trainee Medical Officer (+923320031941 ext. 0915824091, kgmcite15@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical field visibility (time frame: The surgical field visibility time frame for propofol vs isoflurane during endoscopic sinus surgery assessed intraoperatively is usually 30-60mins postinduction). The study lists 2 primary outcomes in all. 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 10 Mar 2026.