NCT06907823

Brief Summary

The goal of this clinical trial is to compare the effect of sevoflurane and propofol on analgesia nociception index(ANI) in patients undergoing general anesthesia. The main question it aims to answer is whether propofol anesthesia results in lesser ANI change to a nociceptive stimulation compared to sevoflurane.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 2, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

June 30, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 10, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

March 28, 2025

Last Update Submit

June 8, 2025

Conditions

PropofolSevofluraneAnalgesia Nociception Index

Outcome Measures

Primary Outcomes (1)

  • analgesia nociception index change

    analgesia nociception index value 1-minute before tetanic stimulation and 1-minute after tetanic stimulation

    During anesthesia period

Secondary Outcomes (2)

  • Hemodynamic change

    During anesthesia period

  • Hemodynamic change

    During anesthesia period

Study Arms (2)

Sevoflurane

OTHER
Drug: Sevoflurane

Propofol

OTHER
Drug: propofol

Interventions

propofolDRUG

propofol anesthesia

Propofol
SevofluraneDRUG

sevoflurane anesthesia

Sevoflurane

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American society of anesthesiologists physical status class I or II

You may not qualify if:

  • history of drugs that can affect the central nervous system and autonomic nervous system, such as anticholinergics, betablockers, antidepressants..etc.
  • history of allergic reaction to sevoflurane and/or propofol
  • history of and/or family history of malignant hyperthermia
  • neurodegenerative disorder
  • psychiatric disorder
  • arrhythmia
  • diabetes mellitus
  • drug abuse history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

PropofolSevoflurane

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

March 28, 2025

First Posted

April 2, 2025

Study Start

June 30, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

June 10, 2025

Record last verified: 2025-06