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Comparation Analgesia Efficiency With Propofol Combine Sevoflurane vs Propofol

Primary Purpose

Nociceptive Pain, Analgesic Adverse Reaction, Inhalant Use

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
5mg/kg/h Propofol
Sevoflurane
2 mg/kg/h Propofol
Sponsored by
China International Neuroscience Institution
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Nociceptive Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion criteria:

  • 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
  • anti-convulsive medications at the time
  • unstable angina
  • manifested congestive heart failure
  • expected difficulty airway management

Sites / Locations

  • Xuanwu Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Propofol

Propofol & Sevoflurane

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

PACU duration
Post anesthesia care unit duration(PACU duration). The longer PACU duration indicate the worse situation of the patients
PONV difference between two groups
postoperative nausea and vomiting ratio(PONV) difference between two groups. The more frequency of PONV, the worst comfortable outcome of the patients
Post- operative pain difference between two groups
Post- operative pain difference between two groups using VAS(Visual analogue rating) Score evaluation. Pain was assessed 24 h post operation using a 0-10 numeric pain rating scale (VAS scale), where zero meant no pain and 10 meant the worst imaginable pain.VAS score (Post-operation 24 h) (0-1 VAS indicate None pain; 2-5 VAS indicate Moderate pain; 6-10 VAS indicate severe pain)

Full Information

First Posted
January 19, 2019
Last Updated
October 10, 2020
Sponsor
China International Neuroscience Institution
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1. Study Identification

Unique Protocol Identification Number
NCT03841812
Brief Title
Comparation Analgesia Efficiency With Propofol Combine Sevoflurane vs Propofol
Official Title
Comparation Analgesia Efficiency With Propofol Combine Sevoflurane vs Propofol Using Index of Nociception (NOX)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 20, 2020 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China International Neuroscience Institution

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
This study purpose to compare analgesia efficiency of propofol combine with sevoflurane with propofol only using index of Nociception (NOX)
Detailed Description
Recently study found sevoflurane plays an important role through spinal nerve peptide receptor (NK.1R), glycine receptor (GlyR), neuron nicotinic receptor (nnAChRs), Methyl-1-methyl-1-day aspartate (NMDA receptor), and TRPV1 receptor (TRPV1 receptor) produce the analgesic efficiency. propofol was traditional sedation reagent. index of Nociception (NOX) was the objective index for analgesia This study purpose to compare analgesia efficiency of Only Propofol and sevoflurane combine with propofol using index of Nociception (NOX)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nociceptive Pain, Analgesic Adverse Reaction, Inhalant Use

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propofol
Arm Type
Experimental
Arm Description
5mg/kg/h Propofol continue infusion during the maintain of anesthesia during the maintain of anesthesia.
Arm Title
Propofol & Sevoflurane
Arm Type
Experimental
Arm Description
2mg/kg/h Propofol & 1% Sevoflurane group continue infusion(Balance anesthesia) during the maintain of anesthesia
Intervention Type
Drug
Intervention Name(s)
5mg/kg/h Propofol
Other Intervention Name(s)
5mg/kg/h Propofol Injection
Intervention Description
5mg/kg/h Propofol continuously infused during intre-operation
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
1% Sevoflurane
Intervention Description
1% Sevoflurane continuously using during intre-operation.
Intervention Type
Drug
Intervention Name(s)
2 mg/kg/h Propofol
Intervention Description
2mg/kg/h Propofol continuously infused during intre-operation
Primary Outcome Measure Information:
Title
qNOX change
Description
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.
Time Frame
during operation
Secondary Outcome Measure Information:
Title
PACU duration
Description
Post anesthesia care unit duration(PACU duration). The longer PACU duration indicate the worse situation of the patients
Time Frame
24 hours
Title
PONV difference between two groups
Description
postoperative nausea and vomiting ratio(PONV) difference between two groups. The more frequency of PONV, the worst comfortable outcome of the patients
Time Frame
24 hours
Title
Post- operative pain difference between two groups
Description
Post- operative pain difference between two groups using VAS(Visual analogue rating) Score evaluation. Pain was assessed 24 h post operation using a 0-10 numeric pain rating scale (VAS scale), where zero meant no pain and 10 meant the worst imaginable pain.VAS score (Post-operation 24 h) (0-1 VAS indicate None pain; 2-5 VAS indicate Moderate pain; 6-10 VAS indicate severe pain)
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion criteria: 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 anti-convulsive medications at the time unstable angina manifested congestive heart failure expected difficulty airway management
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ke Huang, MS
Organizational Affiliation
Xuanwu Hospital, Beijing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xuanwu Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China

12. IPD Sharing Statement

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Comparation Analgesia Efficiency With Propofol Combine Sevoflurane vs Propofol

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