Comparison of Two Sedative Agents in Terms of Controlled Hypotension
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Propofol, Isoflurane.
- Who it may be relevant to
- Registry conditions: Controlled Hypotension for Nasal Surgeries. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
COMPARISON OF PROPOFOL INFUSION VS INHALATIONAL AGENT ISOFLURANE IN TERMS OF CONTROLLED HYPOTENSION IN PATIENTS UNDERGOING ENDOSCOPIC SINUS SURGERY
Overview
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
Interventions
- 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 - Drug Isoflurane
Isoflurane inhalation (1-2% end tidal) used in patients as sedative undergoing endoscopic sinus surgery for hemodynamic stability
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Pakistan · 1 center
- Hayatabad Medical Complex, Peshawar — Peshawar
Identifiers
NCT: NCT07460050 · ISO-PROP-01