Effect of Mannitol on Propofol Level

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

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-20

Study Completion Date

2025-10-30

Brief Summary

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

Group 1 will include 20 patients aged 18 years and over, American Society of Anesthesiologist (ASA) II-III class, who will undergo supratentorial tumor surgery, and Group 2 will include 20 patients who will undergo pituitary surgery without mannitol. Total intravenous anesthesia (TIVA) will be adjusted to propofol 4 µg/dl and remifentanil 2-4 µg/dl with target-controlled infusion pumps. In the mannitol group, 2.5 ml/kg (0.5 g/kg) will be given to all patients 20 minutes after induction and the mannitol infusion will be adjusted to be 10 minutes.In Group 2, mannitol will not be used and 2.5 ml/kg isotonic will be administered in 10 minutes. Both blood and urine samples will take for measurement to propofol levels.

Related Clinical Trials

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

Comparison of Propofol Requirement Between Patients With Pituitary Somatotroph Tumor and With Nonfunctioning Pituitary Tumor in Transsphenoidal Pituitary Surgery Under Total Intravenous Anesthesia

NCT03465423

Pituitary Tumor

COMPLETED

Comparison of Ciprofol and Propofol Under IoC1 and IoC2 Monitoring for Adenotonsillectomy

NCT06882980

Adenotonsillectomy Propofol Ciprofol

RECRUITING NA

The Effects of Propofol and Thiopental on Nitric Oxide Production and Release in Erythrocytes

NCT06485388

Effect of Drug

COMPLETED NA

The Effect of Blood Pressure on Cerebral Blood Flow During Propofol Anesthesia

NCT03309917

Gastrointestinal Neoplasms Anesthesia, General

COMPLETED NA

Etomidate/Propofol Mixture or Propofol Monotherapy Use in Patients Undergoing General Anesthesia

NCT03855267

Etomidate is Mixed With Propofol

UNKNOWN NA

Detailed Description

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

The participants will divide into the two groups. Group 1 will include 20 patients aged 18 years and over, American Society of Anesthesiologist (ASA) II-III class, who will undergo supratentorial tumor surgery, (Mannitol group) and Group 2 will include 20 patients who will undergo pituitary surgery without mannitol (Control Group). Total intravenous anesthesia (TIVA) will be adjusted to propofol 4 µg/dl and remifentanil 2-4 µg/dl with target-controlled infusion pumps. In the mannitol group, 2.5 ml/kg (0.5 g/kg) will be given to all patients 20 minutes after induction and the mannitol infusion will be adjusted to be 10 minutes.In Group 2, mannitol will not be used and 2.5 ml/kg isotonic will be administered in 10 minutes. Both blood and urine samples will take for measurement to propofol levels. Beside to standard monitoring invasive hemodynamic monitorization (cardiac output, cardiac index, stroke volume variability) and bispectral index will apply to the all participants.

Conditions

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

Mannitol Adverse Reaction

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

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mannitol

2.5 ml/kg (0.5 g/kg) Mannitol will be given to all patients 15 minutes after induction and the mannitol infusion will be adjusted to be 10 minutes.

Group Type ACTIVE_COMPARATOR

mannitol

Intervention Type DRUG

2.5 mg/kg Mannitol will be given intravenously

Saline

2.5 ml/kg saline will be given to patients 15 minutes after induction and the infusion will be adjusted to be 10 minutes.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type OTHER

2.5 ml/kg saline will be given as plasebo

Interventions

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

mannitol

2.5 mg/kg Mannitol will be given intravenously

Intervention Type DRUG

Saline

2.5 ml/kg saline will be given as plasebo

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* American Society of Anesthesiologist (ASA) II participants
* supratentorial tumor surgery
* eligible for mannitol use
* eligible for Total intravenous anesthesia (TIVA)