Different Anesthesia Maintain Protocol Effect the Outcome of the Patients

China International Neuroscience Institution

Status and phase: Completed; Phase 4

Conditions: General Anesthesia; Urinary Surgery

Treatments: Drug: Propofol half; Drug: 1% Sevoflurane; Drug: 2% Sevoflurane; Drug: Sufentanil; Drug: 1% Sevoflurane continue; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT04443946

CINI-AD-20205-19

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 5 patient groups

Group-P

Active Comparator group

Description:

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

Treatment:

Drug: Propofol

Group-PAS

Experimental group

Description:

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.

Treatment:

Drug: 1% Sevoflurane

Drug: Propofol half

Group-PS

Experimental group

Description:

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.

Treatment:

Drug: 1% Sevoflurane continue

Drug: Propofol half

Group-S

Experimental group

Description:

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

Treatment:

Drug: 2% Sevoflurane

Group-PSu

Experimental group

Description:

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

Treatment:

Drug: Sufentanil

Drug: Propofol