NCT03841812

Brief Summary

This study purpose to compare analgesia efficiency of propofol combine with sevoflurane with propofol only using index of Nociception (NOX)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
146

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2020

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

January 19, 2019

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
11 months until next milestone

Study Start

First participant enrolled

January 20, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

October 14, 2020

Status Verified

January 1, 2020

Enrollment Period

4 months

First QC Date

January 19, 2019

Last Update Submit

October 10, 2020

Conditions

Nociceptive PainAnalgesic Adverse ReactionInhalant Use

Outcome Measures

Primary Outcomes (1)

  • qNOX change

    Nociception of index (qNOX) difference between two groups. The nociception index (NOX) derived from electroencephalogram (EEG) signals has been proposed as a noninvasive guide to indicate anesthesia depth. The neurological processing of noxious stimuli is defined as nociception. NOX ranges from 0-99, and the lower the index, the deeper the state of analgesia. NOX lower than 20 represents deep analgesia, and higher than 80 represents inadequate analgesia.

    during operation

Secondary Outcomes (3)

  • PACU duration

    24 hours

  • PONV difference between two groups

    24 hours

  • Post- operative pain difference between two groups

    24 hours

Study Arms (2)

Propofol

EXPERIMENTAL

5mg/kg/h Propofol continue infusion during the maintain of anesthesia during the maintain of anesthesia.

Drug: 5mg/kg/h Propofol

Propofol & Sevoflurane

EXPERIMENTAL

2mg/kg/h Propofol \& 1% Sevoflurane group continue infusion(Balance anesthesia) during the maintain of anesthesia

Drug: SevofluraneDrug: 2 mg/kg/h Propofol

Interventions

5mg/kg/h PropofolDRUG

5mg/kg/h Propofol continuously infused during intre-operation

Also known as: 5mg/kg/h Propofol Injection
Propofol
SevofluraneDRUG

1% Sevoflurane continuously using during intre-operation.

Also known as: 1% Sevoflurane
Propofol & Sevoflurane
2 mg/kg/h PropofolDRUG

2mg/kg/h Propofol continuously infused during intre-operation

Propofol & Sevoflurane

Eligibility Criteria

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

You may qualify if:

  • Participants were aged 18-65 years old,
  • American Society of Anesthesiologists (ASA) physical status I, II or III
  • scheduled to have urological surgery(would last longer than 1 h)
  • requiring general anesthesia.

You may not qualify if:

  • refused to participate in this study;
  • Unable to communicate normally because of consciousness alterations;
  • a history of allergy to opioids
  • contraindications to inhalational anesthesia
  • a family history of malignant hyperthermia
  • a history of alcohol or drug abuse
  • received central nervous system-active drugs
  • super obese as defined by a body mass index ≥40 kg/m2
  • conditions liable to alter the pharmacokinetic and pharmacodynamic behaviors of the intravenous and inhalation anesthetics
  • previous head injury
  • neurologic
  • psychiatric disease
  • any disabling central nervous
  • cerebrovascular disease
  • using psychoactive
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Nociceptive Pain

Interventions

PropofolSevoflurane

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Ke Huang, MS

    Xuanwu Hospital, Beijing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2019

First Posted

February 15, 2019

Study Start

January 20, 2020

Primary Completion

June 1, 2020

Study Completion

July 1, 2020

Last Updated

October 14, 2020

Record last verified: 2020-01

Locations

CN(1)