Comparison Between Opioid-Free Anaesthesia Versus Opioid Based Anesthesia in Reduction Postoperative Nausea and Vomiting (PONV)After Thoracoscopic Lung Resection.

September 1, 2026 updated by: Islam Mokhtar Ahmed, Sohag University

Comparison Between Opioid-Free Anaesthesia Versus Opioid Based Anesthesia in Reduction Postoperative Nausea and Vomiting (PONV)After Thoracoscopic Lung Resection. A Prospective Randomised Controlled Trial)

The invistigators hypothesized that a protocolized OFA technique would lower the occurance of PONV in patients undergoing thoracoscopic lung surgery compared to standard opioid-based anaesthesia.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:-

  • Eligible participants were adults (18-80 years).
  • Prepared for elective thoracoscopic lobectomy or segmentectomy for lung cancer under general anaesthesia

Exclusion Criteria:

  • Contraindication to any study drug (e.g., heart block, severe liver disease, allergy).
  • Chronic opioid use (>30 MME/day for >3 months).
  • Patients with renal impairment (e GFR <30 mL/min).
  • Pregnancy.
  • Inability to comprehend pain scales.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: conventential opioid-based anaesthesia (OBA, n=60).
Drug: conventential opioid-based anaesthesia (OBA,
The OBA group protocol consists of balanced anaesthesia with fentanyl plus sevoflurane.
Experimental: opioid free anesthesia( OFA , n=60)
Drug: Opioid Free Anaesthesia
The OFA group protocol consists of a combination of intravenous lidocaine, ketamine, dexmedetomidine, and propofol TIVA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the occurrence of PONV during the initial 24 hours
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
total opioid consumption over 24 hour (expressed as morphine milligram equivalents.
Time Frame: 24 hours
24 hours
pain intensity scores (numerical rating scale NRS 0-10)
Time Frame: 24 hours
24 hours
recovery quality (QoR-15 score)
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

October 20, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

August 25, 2026

First Submitted That Met QC Criteria

September 1, 2026

First Posted (Actual)

September 8, 2026

Study Record Updates

Last Update Posted (Actual)

September 8, 2026

Last Update Submitted That Met QC Criteria

September 1, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-26-6-14PD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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