Anesthesia Techniques, Neuroprotection and Surgical Field in FESS Under Controlled Hypotension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-11

Study Completion Date

2026-03-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This prospective, randomized controlled trial investigates the effect of four different anesthetic maintenance techniques on surgical field conditions, hemodynamic stability, and neuroprotection during functional endoscopic sinus surgery (FESS) performed under controlled hypotension. Patients are randomly assigned to receive either total intravenous anesthesia with propofol-remifentanil, propofol-remifentanil with adjunct ketamine and magnesium, sevoflurane-remifentanil, or sevoflurane-remifentanil with adjunct ketamine and magnesium. Primary outcomes include serum biomarkers of neuronal injury (S100B and neuron-specific enolase, NSE) measured perioperatively, as well as surgical field visibility and intraoperative bleeding scores. Secondary outcomes include recovery profile and postoperative pain.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison Between Two Drugs (Propofol and Nitroglycerin as a Hypotensive Agents During Endoscopic Sinus Surgery

NCT04220281

Hypotensive Anesthesia

TERMINATED PHASE1/PHASE2

Propofol and Magnesium Sulfate Intravenous Infusion During Endoscopic Sinus Surgery

NCT04078659

Endoscopic Sinus Surgery

UNKNOWN NA

SPI-guided vs PRD-guided Analgesia During FESS for Intraoperative Blood Loss

NCT03389763

Endoscopic Sinus Surgery

COMPLETED NA

Opioid Free Anesthesia in ENT Surgery

NCT04105946

Functional Endoscopic Sinus Surgery

UNKNOWN NA

Comparative Effect of Hypotensive Anaesthesia on Event Related Potentials, Quantitative Electroencephalograghy

NCT04110808

Effect of Drugs

UNKNOWN EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Functional endoscopic sinus surgery (FESS) is commonly performed under controlled hypotension in order to minimize intraoperative bleeding and optimize the surgical field. However, controlled hypotension may pose a risk of cerebral hypoperfusion and neuronal injury. This prospective, single-center randomized controlled study aims to compare four anesthetic maintenance regimens: (1) propofol-remifentanil, (2) propofol-remifentanil plus continuous ketamine and magnesium infusion, (3) sevoflurane-remifentanil, and (4) sevoflurane-remifentanil plus continuous ketamine and magnesium infusion.

The primary objectives are to evaluate differences in serum S100B and NSE levels at three perioperative time points (baseline before incision, 20 minutes after initiation of controlled hypotension, and at the end of surgery), as well as surgical field quality (7-point Likert scale) and intraoperative bleeding (0-5 scale) as rated by blinded surgeons. Secondary objectives include assessment of extubation conditions with the Aldrete score and evaluation of postoperative pain using a visual analogue scale (VAS). The findings of this trial may help determine whether adjunct agents with potential neuroprotective properties, such as ketamine and magnesium, provide additional benefit during FESS under controlled hypotension.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Magnesium Sulfate Remifentanil S 100beta S100 Beta Protein, Human Neuron-Specific Enolase Brain Ischemia Sevoflurane Anaesthesia Propofol/Remifentanil Ketamine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

The surgeon who rates the surgical field and the investigator responsible for data analysis are blinded to group allocation. The anesthesiologist is aware of the intervention for safety and drug-delivery reasons.

Intervention Type DRUG

Continuous intraoperative infusion per protocol.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Propofol / Remifentanil

Maintenance of general anesthesia with propofol and remifentanil; no ketamine or magnesium administered.

Intervention Type DRUG

Ketamine + Magnesium sulfate (drug combination)

Continuous intraoperative infusion per protocol.

Intervention Type DRUG

Sevoflurane and Remifentanil

Continuous intraoperative infusion per protocol.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Adult patients (≥18 years old). Scheduled for F.E.S.S (Functional endoscopic sinus surgery ) under general anesthesia.

Able to provide informed consent

Exclusion Criteria

Emergency surgery. ASA physical status IV-V. Severe hepatic or renal dysfunction. Known allergy or contraindication to study drugs. Pregnant or lactating women. unable to provide informed consent

Patients unwilling or unable to provide consent.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No