NCT07806162

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Sep 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress55%
Sep 2026Nov 2026

First Submitted

Initial submission to the registry

August 25, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 8, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2026

Expected
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

September 8, 2026

Status Verified

August 1, 2026

Enrollment Period

2 months

First QC Date

August 25, 2026

Last Update Submit

September 1, 2026

Conditions

PONV

Outcome Measures

Primary Outcomes (1)

  • the occurrence of PONV during the initial 24 hours

    24 hours

Secondary Outcomes (3)

  • total opioid consumption over 24 hour (expressed as morphine milligram equivalents.

    24 hours

  • pain intensity scores (numerical rating scale NRS 0-10)

    24 hours

  • recovery quality (QoR-15 score)

    24 hours

Study Arms (2)

conventential opioid-based anaesthesia (OBA, n=60).

PLACEBO COMPARATOR
Drug: conventential opioid-based anaesthesia (OBA,

opioid free anesthesia( OFA , n=60)

EXPERIMENTAL
Drug: Opioid Free Anaesthesia

Interventions

conventential opioid-based anaesthesia (OBA,DRUG

The OBA group protocol consists of balanced anaesthesia with fentanyl plus sevoflurane.

conventential opioid-based anaesthesia (OBA, n=60).
Opioid Free AnaesthesiaDRUG

The OFA group protocol consists of a combination of intravenous lidocaine, ketamine, dexmedetomidine, and propofol TIVA.

opioid free anesthesia( OFA , n=60)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Anesthesia and Intensive Care

Study Record Dates

First Submitted

August 25, 2026

First Posted

September 8, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

October 20, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

September 8, 2026

Record last verified: 2026-08