Comparison of Two Sedative Agents in Terms of Controlled Hypotension

March 4, 2026 updated by: Amina Sultan, Hayatabad Medical Complex

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dr. Laiba Khalid, Trainee Medical Officer
  • Phone Number: 0915824091 +923320031941
  • Email: kgmcite15@gmail.com

Study Contact Backup

  • Name: Dr. Laiba Khalid, Trainee Medical Officer
  • Phone Number: +923320031941 03320031941
  • Email: kgmcite15@gmail.com

Study Locations

  • Pakistan
    • Khyber Pakhtunkhwa
      • Peshawar, Khyber Pakhtunkhwa, Pakistan, 25000
        • Hayatabad Medical Complex, Peshawar
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Either male/female Age 18-65 Patients undergoing endoscopic sinus surgery as per the operational definition

Exclusion Criteria:

  • Patients with cardiovascular disease Patients with pregnancy Patients with coagulopathy Patients on beta blockers or calcium channel blockers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient receiving Propofol infusion for controlled hypotention during surgery under general anaes
Intravenous propfol infusion (starting 12mg/kg/hr) adminitration intraoperatively as sedative for controlled hypotension during endoscopic sinus surgery
Drug: Propofol
Intravenous propofol infusion (starting dose 12mg/kg/hr and titrated accordingly) given to patients as sedative undergoing endscopic sinus surgery for hemodynamic stability
Active Comparator: Isoflurane inhalation for controlled hypotension during surgery under general anaesthesia
Isoflurane inhalation (1-2% end tidal) given intraoperativley as sedative for controlled hypotension during eendoscopic sinus surgery
Drug: Isoflurane
Isoflurane inhalation (1-2% end tidal) used in patients as sedative undergoing endoscopic sinus surgery for hemodynamic stability

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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 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
The surgical field visibility time frame assessed intraoperatively during endoscopic sinus surgery is usually 30- 60 mins post induction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hayatabad Medical Complex

Investigators

  • Study Chair: Dr. Laiba Khalid, Postgraduate trainee, Hayat Abad Medical Complex, Peshawar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 4, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISO-PROP-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to patient confidentiality and institutional policies

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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