Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:41 AM
Study NCT ID:
NCT07460050
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-10
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Sedative Agents in Terms of Controlled Hypotension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D007530', 'term': 'Isoflurane'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 136}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-04', 'studyFirstSubmitDate': '2026-03-04', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical field visibility', 'timeFrame': 'The surgical field visibility time frame for propofol vs isoflurane during endoscopic sinus surgery assessed intraoperatively is usually 30-60mins postinduction'}, {'measure': 'Surgical field visibility', 'timeFrame': 'The surgical field visibility time frame assessed intraoperatively during endoscopic sinus surgery is usually 30- 60 mins post induction'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Controlled hypotention', 'Propofol infusion', 'Endoscopic sinus surgery', 'Isoflurane inhalation'], 'conditions': ['Controlled Hypotension for Nasal Surgeries']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nIsoflurane 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Either male/female Age 18-65 Patients undergoing endoscopic sinus surgery as per the operational definition\n\nExclusion Criteria:\n\n* Patients with cardiovascular disease Patients with pregnancy Patients with coagulopathy Patients on beta blockers or calcium channel blockers'}, 'identificationModule': {'nctId': 'NCT07460050', 'briefTitle': 'Comparison of Two Sedative Agents in Terms of Controlled Hypotension', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hayatabad Medical Complex'}, 'officialTitle': 'COMPARISON OF PROPOFOL INFUSION VS INHALATIONAL AGENT ISOFLURANE IN TERMS OF CONTROLLED HYPOTENSION IN PATIENTS UNDERGOING ENDOSCOPIC SINUS SURGERY', 'orgStudyIdInfo': {'id': 'ISO-PROP-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient receiving Propofol infusion for controlled hypotention during surgery under general anaes', 'description': 'Intravenous propfol infusion (starting 12mg/kg/hr) adminitration intraoperatively as sedative for controlled hypotension during endoscopic sinus surgery', 'interventionNames': ['Drug: Propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Isoflurane inhalation for controlled hypotension during surgery under general anaesthesia', 'description': 'Isoflurane inhalation (1-2% end tidal) given intraoperativley as sedative for controlled hypotension during eendoscopic sinus surgery', 'interventionNames': ['Drug: Isoflurane']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'description': 'Intravenous propofol infusion (starting dose 12mg/kg/hr and titrated accordingly) given to patients as sedative undergoing endscopic sinus surgery for hemodynamic stability', 'armGroupLabels': ['Patient receiving Propofol infusion for controlled hypotention during surgery under general anaes']}, {'name': 'Isoflurane', 'type': 'DRUG', 'description': 'Isoflurane inhalation (1-2% end tidal) used in patients as sedative undergoing endoscopic sinus surgery for hemodynamic stability', 'armGroupLabels': ['Isoflurane inhalation for controlled hypotension during surgery under general anaesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Peshawar', 'state': 'Khyber Pakhtunkhwa', 'country': 'Pakistan', 'contacts': [{'name': 'Laiba Khalid, Trainee Medical Officer', 'role': 'CONTACT', 'email': 'kgmcite15@gmail.com', 'phone': '03320031941'}], 'facility': 'Hayatabad Medical Complex, Peshawar', 'geoPoint': {'lat': 34.008, 'lon': 71.57849}}], 'centralContacts': [{'name': 'Dr. Laiba Khalid, Trainee Medical Officer', 'role': 'CONTACT', 'email': 'kgmcite15@gmail.com', 'phone': '+923320031941', 'phoneExt': '0915824091'}, {'name': 'Dr. Laiba Khalid, Trainee Medical Officer', 'role': 'CONTACT', 'email': 'kgmcite15@gmail.com', 'phone': '03320031941', 'phoneExt': '+923320031941'}], 'overallOfficials': [{'name': 'Dr. Laiba Khalid, Postgraduate trainee', 'role': 'STUDY_CHAIR', 'affiliation': 'Hayat Abad Medical Complex, Peshawar'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared due to patient confidentiality and institutional policies'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hayatabad Medical Complex', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Amina Sultan', 'investigatorAffiliation': 'Hayatabad Medical Complex'}}}}