Clinical trial NCT04443946: Different Anesthesia Maintain Protocol Effect the Outcome of the Patients
Official title: Different Anesthesia Maintain Protocol Effect the Outcome of the Patients Undergoing General Anesthesia for Urinary Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Surgery
General Anesthesia
Lead sponsor: China International Neuroscience Institution
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Extubation Duration(ED)
timeFrame: Up to 24 hours
Secondary outcomes:
measure: Length of PACU
timeFrame: Up to 24 hours
measure: qNOX
timeFrame: From entering the operation room until the discharge from the operation room, assessed up to 12 hours
measure: Bis
timeFrame: From entering the operation room until the discharge from the operation room, assessed up to 12 hours
measure: Blood pressure
timeFrame: From entering the operation room until the discharge from the operation room, assessed up to 12 hours
measure: The heart rate
timeFrame: From entering the operation room until the discharge from the operation room, assessed up to 12 hours
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu hospital
state: Beijing
Study officials:
affiliation: China International Neuroscience Institution
name: Yanghai Cui
role: STUDY_CHAIR
References: