Different Anesthesia Maintain Protocol Effect the Outcome of the Patients

NCT04443946 | Completed Phase 4 DMC

• 1 other identifier: CINI-AD-20205-19
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Urinary Surgery; General Anesthesia

Outcome Measures

Primary Outcomes (1)

• Extubation Duration(ED)

  the extubation Duration (ED) was calculated as the time from the end of anesthesia to extubation of the LMA

  Up to 24 hours

Secondary Outcomes (5)

• Length of PACU

  Up to 24 hours

• qNOX

  From entering the operation room until the discharge from the operation room, assessed up to 12 hours

• Bis

  From entering the operation room until the discharge from the operation room, assessed up to 12 hours

• Blood pressure

  From entering the operation room until the discharge from the operation room, assessed up to 12 hours

• The heart rate

  From entering the operation room until the discharge from the operation room, assessed up to 12 hours

Study Arms (5)

Group-P

ACTIVE COMPARATOR

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

Drug: Propofol

Group-PAS

EXPERIMENTAL

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; Drug: Propofol half

Group-PS

EXPERIMENTAL

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; Drug: Propofol half

Group-S

EXPERIMENTAL

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

Drug: 2% Sevoflurane

Group-PSu

EXPERIMENTAL

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; Drug: Sufentanil

Interventions

Propofol DRUG

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

Group-P; Group-PSu

1% Sevoflurane DRUG

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

Group-PAS

1% Sevoflurane continue DRUG

1% sevoflurane continued to maintain anesthesia after endotracheal intubation.

Also known as: 1% Sevoflurane

Group-PS

Sufentanil DRUG

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

Group-PSu

2% Sevoflurane DRUG

2% sevoflurane continued to maintain anesthesia after endotracheal intubation.

Also known as: 2% Sevoflurane continue

Group-S

Propofol half DRUG

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

Also known as: 2.5% Propofol

Group-PAS; Group-PS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China International Neuroscience Institution: lead

Study Sites (1)

Xuanwu hospital

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Interventions

Propofol; Sevoflurane; Sufentanil

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yanghai Cui

  China International Neuroscience Institution

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 23, 2020
• Study Start: June 25, 2020
• Primary Completion: August 5, 2020
• Study Completion: August 5, 2020
• Last Updated: October 14, 2020

Record last verified: 2020-06

Locations

CN (1)