Different Anesthesia Maintain Protocol Effect the Outcome of the Patients

Sponsor

China International Neuroscience Institution (Other)

Overall Status

Completed

CT.gov ID

NCT04443946

Collaborator

(none)

Enrollment

Location

Arms

1.3

Actual Duration (Months)

37.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Urinary Surgery General Anesthesia	Drug: Propofol Drug: 1% Sevoflurane Drug: 1% Sevoflurane continue Drug: Sufentanil Drug: 2% Sevoflurane Drug: Propofol half	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Different Anesthesia Maintain Protocol Effect the Outcome of the Patients Undergoing General Anesthesia for Urinary Surgery

Actual Study Start Date :

Jun 25, 2020

Actual Primary Completion Date :

Aug 5, 2020

Actual Study Completion Date :

Aug 5, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group-P Group-P: (Propofol group): 5 mg kg-1 h-1 propofol was pumped continuously after endotracheal intubation.	Drug: Propofol 5 mg kg-1 h-1 propofol was pumped continuously after endotracheal intubation.
Experimental: 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.	Drug: 1% Sevoflurane add 1% end-tidal sevoflurane 20 minutes after endotracheal intubation. Drug: Propofol half 2.5 mg kg-1 h-1 propofol was pumped continuously after endotracheal intubation. Other Names: 2.5% Propofol
Experimental: 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.	Drug: 1% Sevoflurane continue 1% sevoflurane continued to maintain anesthesia after endotracheal intubation. Other Names: 1% Sevoflurane Drug: Propofol half 2.5 mg kg-1 h-1 propofol was pumped continuously after endotracheal intubation. Other Names: 2.5% Propofol
Experimental: Group-S Group-S: (Sevoflurane group): 2% sevoflurane continued to maintain anesthesia after endotracheal intubation.	Drug: 2% Sevoflurane 2% sevoflurane continued to maintain anesthesia after endotracheal intubation. Other Names: 2% Sevoflurane continue
Experimental: 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	Drug: Propofol 5 mg kg-1 h-1 propofol was pumped continuously after endotracheal intubation. Drug: Sufentanil 0.01 μ g kg-1 min-1 sufentanil were pumped continuously at maintain phase

Outcome Measures

Primary Outcome Measures

Extubation Duration(ED) [Up to 24 hours]
the extubation Duration (ED) was calculated as the time from the end of anesthesia to extubation of the LMA

Secondary Outcome Measures

Length of PACU [Up to 24 hours]
Length of PACU (Post-anesthesia care unit): From entering the PACU to discharge from the PACU
qNOX [From entering the operation room until the discharge from the operation room, assessed up to 12 hours]
Noceciption index,The qNOX of depth of analgesia also ranges from 99 to 0, and usually it is controlled to be within 40-60 during the operative period, with qNOX > 80 indicating an insufficient use of analgesic agents and qNOX < 10 indicating excessive analgesic effects.
Bis [From entering the operation room until the discharge from the operation room, assessed up to 12 hours]
Bispectral index,Bis 50-80 means appropriate Sedation depth
Blood pressure [From entering the operation room until the discharge from the operation room, assessed up to 12 hours]
measuring Systolic, Diastolic and Mean Blood Pressure
The heart rate [From entering the operation room until the discharge from the operation room, assessed up to 12 hours]
The heart rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xuanwu hospital	Beijing	Beijing	China	100053

Sponsors and Collaborators

China International Neuroscience Institution

Investigators

Study Chair: Yanghai Cui, China International Neuroscience Institution

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

China International Neuroscience Institution

ClinicalTrials.gov Identifier:

NCT04443946

Other Study ID Numbers:

CINI-AD-20205-19

First Posted:

Jun 23, 2020

Last Update Posted:

Oct 14, 2020

Last Verified:

Jun 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Sufentanil

Propofol

Sevoflurane

Study Results

No Results Posted as of Oct 14, 2020