Different Anesthesia Maintain Protocol Effect the Outcome of the Patients

NCT ID: NCT04443946

Last Updated: 2020-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-25

Study Completion Date

2020-08-05

Brief Summary

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This prospective open-label randomized study, patients were having elective urological surgery scheduled to last longer than 1 h under necessitating general anesthesia.Group-P: (Propofol group): 3 mg kg-1 min-1 propofol was pumped continuously after endotracheal intubation. Group-PAS: (Propofol and after 20 min adding Sevoflurane group): 3 mg kg-1 min-1 propofol were pumped continuously and add 1% end-tidal sevoflurane 20 minutes after endotracheal intubation. Group-PS: (Propofol and Sevoflurane group): 3 mg kg-1 min-1 propofol were continuously pumped after endotracheal intubation, and 1% sevoflurane was inhaled continuously at the same time. Group-S: (Sevoflurane group): 1% sevoflurane continued to maintain anesthesia after endotracheal intubation. Group-PSu: (Propofol and Sufentanil group): 3 mg kg-1 min-1 propofol, 0.01 μ g kg-1 min-1 sufentanil were pumped continuously at maintain phase

Detailed Description

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Group-P: (Propofol group): 3 mg kg-1 min-1 propofol was pumped continuously after endotracheal intubation. Group-PAS: (Propofol and after 20 min adding Sevoflurane group): 3 mg kg-1 min-1 propofol were pumped continuously and add 1% end-tidal sevoflurane 20 minutes after endotracheal intubation. Group-PS: (Propofol and Sevoflurane group): 3 mg kg-1 min-1 propofol were continuously pumped after endotracheal intubation, and 1% sevoflurane was inhaled continuously at the same time. Group-S: (Sevoflurane group): 1% sevoflurane continued to maintain anesthesia after endotracheal intubation. Group-PSu: (Propofol and Sufentanil group): 3 mg kg-1 min-1 propofol, 0.01 μ g kg-1 min-1 sufentanil were pumped continuously at maintain phase. Due to the ethical requirements of adequent analgesia, 0.3 μ g kg-1 min-1 remifentanil was continuously pumped as background input dose during anesthesia maintenance in all groups.

Conditions

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Urinary Surgery General Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group-P

Group-P: (Propofol group): 5 mg kg-1 h-1 propofol was pumped continuously after endotracheal intubation.

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

5 mg kg-1 h-1 propofol was pumped continuously after endotracheal intubation.

Group-PAS

Group-PAS: (Propofol and after 20 min adding Sevoflurane group): 2.5 mg kg-1 h-1 propofol were pumped continuously and add 1% end-tidal sevoflurane 20 minutes after endotracheal intubation.

Group Type EXPERIMENTAL

1% Sevoflurane

Intervention Type DRUG

add 1% end-tidal sevoflurane 20 minutes after endotracheal intubation.

Propofol half

Intervention Type DRUG

2.5 mg kg-1 h-1 propofol was pumped continuously after endotracheal intubation.

Group-PS

Group-PS: (Propofol and Sevoflurane group): 2.5 mg kg-1 h-1 propofol were continuously pumped after endotracheal intubation, and 1% sevoflurane was inhaled continuously at the same time.

Group Type EXPERIMENTAL

1% Sevoflurane continue

Intervention Type DRUG

1% sevoflurane continued to maintain anesthesia after endotracheal intubation.

Propofol half

Intervention Type DRUG

2.5 mg kg-1 h-1 propofol was pumped continuously after endotracheal intubation.

Group-S

Group-S: (Sevoflurane group): 2% sevoflurane continued to maintain anesthesia after endotracheal intubation.

Group Type EXPERIMENTAL

2% Sevoflurane

Intervention Type DRUG

2% sevoflurane continued to maintain anesthesia after endotracheal intubation.

Group-PSu

Group-PSu: (Propofol and Sufentanil group): 5 mg kg-1 h-1 propofol, 0.01 μ g kg-1 min-1 sufentanil were pumped continuously at maintain phase

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

5 mg kg-1 h-1 propofol was pumped continuously after endotracheal intubation.

Sufentanil

Intervention Type DRUG

0.01 μ g kg-1 min-1 sufentanil were pumped continuously at maintain phase

Interventions

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Propofol

5 mg kg-1 h-1 propofol was pumped continuously after endotracheal intubation.

Intervention Type DRUG

1% Sevoflurane

add 1% end-tidal sevoflurane 20 minutes after endotracheal intubation.

Intervention Type DRUG

1% Sevoflurane continue

1% sevoflurane continued to maintain anesthesia after endotracheal intubation.

Intervention Type DRUG

Sufentanil

0.01 μ g kg-1 min-1 sufentanil were pumped continuously at maintain phase

Intervention Type DRUG

2% Sevoflurane

2% sevoflurane continued to maintain anesthesia after endotracheal intubation.

Intervention Type DRUG

Propofol half

2.5 mg kg-1 h-1 propofol was pumped continuously after endotracheal intubation.

Intervention Type DRUG

Other Intervention Names

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1% Sevoflurane 2% Sevoflurane continue 2.5% Propofol

Eligibility Criteria

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Inclusion Criteria

* the aged 18-65 yr,
* ASA physical status I, II or III patients
* having elective urological surgery
* operation scheduled to last longer than 1 h
* under necessitating general anesthesia

Exclusion Criteria

* refused to participate in the study;
* were not able to communicate due to alterations in the level of consciousness, - a history of allergy to opioids
* contraindications inhalational anaesthesia
* family history of malignant hyperthermia
* alcohol or drug abuse
* received central nervous system-active drugs;
* body mass index ≥40 kg/m2
* represent conditions liable to alter the pharmacokinetic and pharmacodynamic behaviors of the intravenous and inhalation anesthetics
* previous head injury, neurologic or psychiatric disease
* any disabling central nervous
* cerebrovascular disease
* current use of psychoactive or anti-convulsive medications
* unstable angina
* manifest congestive heart failure
* airway management was expected to be difficult
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China International Neuroscience Institution

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yanghai Cui

Role: STUDY_CHAIR

China International Neuroscience Institution

Locations

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Xuanwu hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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CINI-AD-20205-19

Identifier Type: -

Identifier Source: org_study_id

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