Preemptive Versus Preventive Antiemetic Treatment

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-30

Study Completion Date

2020-11-30

Brief Summary

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

Patients aged between 20 and 70 years, ASA physical status I-III, and scheduled for laparoscopic cholecystectomy under general anaesthesia will be enrolled in the study.

Patients will be randomized to the preemptive group to receive an antiemetic regime 1h before the start of surgery or to the intraoperative group to receive the same antiemetic drugs in the same doses intraoperatively, 30 min before the end of surgery.

In the operating room standard monitoring and a standardized anesthetic technique will be implemented in all patients. Nausea, vomiting, retching and PONV (cumulative) will be recorded at PACU, at 4h, 8h and 24h postoperatively. Pain scores assessed by NRS (numerical rating scale) will be recorded at the same time points. Also, when patients received fluids and solid food by mouth will be recorded.

Related Clinical Trials

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

Role of Droperidol in Postoperative Vomiting

NCT00702442

Vomiting

COMPLETED PHASE4

The Effects of Acupuncture Against Postoperative Nausea and Vomit After Laparoscopic Cholecystectomy

NCT04759079

Postoperative Nausea Postoperative Vomiting Laparoscopic Cholecystectomy +1 more

COMPLETED NA

A 6 Months Double Blind Trial to Prevent PONV in Laparoscopic Cholecystectomy

NCT05529004

Postoperative Nausea and Vomiting

UNKNOWN PHASE2

Ginger to Prevent Nausea and Vomiting After Laparoscopic Cholecystectomy

NCT07190495

Postoperative Nausea and Vomiting Laparoscopic Cholecystectomy

RECRUITING PHASE4

Dimenydrinate vs Ondansetron for PONV (DONV)

NCT05590936

PONV in Laparoscopic Cholocystectomies

COMPLETED NA

Detailed Description

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

Conditions

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

Postoperative Nausea and Vomiting

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

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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

preemptive group

The preemptive group will receive the anti-emetic regimen i.v. (4 mg of ondansetron) 1h before the start of surgery. During surgery, 30 min before the end of operation, this group will receive i.v. 0.9% NaCl in equal volumes.The intervention consists of the different time points of antiemetic treatment, thus 1h before surgery vs intraopertively.

Intervention: Antiemetic treatment 1h before surgery

Group Type ACTIVE_COMPARATOR

Antiemetics perioperatively

Intervention Type OTHER

Preemptive group ondansetron 4 mg will be administered 1h before surgery Intraoperative group Ondansetron 4 mg will be administered intraoperatively

intraoperative group

The preventive group will receive i.v. 0.9% NaCl 1h before surgery and ondansetron 4 mg 30 min before the end of surgery at equal volumes.

Intervention: Antiemetic treatment intraoperatively

Group Type OTHER

Antiemetics perioperatively

Intervention Type OTHER

Preemptive group ondansetron 4 mg will be administered 1h before surgery Intraoperative group Ondansetron 4 mg will be administered intraoperatively

Interventions

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

Antiemetics perioperatively

Preemptive group ondansetron 4 mg will be administered 1h before surgery Intraoperative group Ondansetron 4 mg will be administered intraoperatively

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* ASA physical status I-III patients
* Surgical procedure: scheduled for laparoscopic cholecystectomy
* Type of anesthesia: general

Exclusion Criteria

* Antihistamines the last three days
* Antiemetic drugs the last three days
* Hiatus hernia
* reflux
* Gastrointestinal disease
* Pregnancy
* BMI \> 35
* parkinson
* known allergy to the drugs of the protocol
* epilepsy

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No