Different Anesthesia Maintain Protocol Effect the Outcome of the Patients

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

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

Study Overview

• Status: Completed
• Conditions: General Anesthesia; Urinary Surgery
• Intervention / Treatment: Drug: Propofol; Drug: 1% Sevoflurane; Drug: Propofol half; Drug: 1% Sevoflurane continue; Drug: 2% Sevoflurane; Drug: Sufentanil

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Xuanwu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

5

Arms and Interventions

Participant Group / 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: Propofol half; 2.5 mg kg-1 h-1 propofol was pumped continuously after endotracheal intubation.; Other Names: 2.5% Propofol; Drug: 1% Sevoflurane continue; 1% sevoflurane continued to maintain anesthesia after endotracheal intubation.; Other Names: 1% Sevoflurane
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of PACU	Length of PACU (Post-anesthesia care unit): From entering the PACU to discharge from the PACU	Up to 24 hours
qNOX	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.	From entering the operation room until the discharge from the operation room, assessed up to 12 hours
Bis	Bispectral index,Bis 50-80 means appropriate Sedation depth	From entering the operation room until the discharge from the operation room, assessed up to 12 hours
Blood pressure	measuring Systolic, Diastolic and Mean Blood Pressure	From entering the operation room until the discharge from the operation room, assessed up to 12 hours
The heart rate	The heart rate	From entering the operation room until the discharge from the operation room, assessed up to 12 hours

Collaborators and Investigators

• Sponsor: China International Neuroscience Institution
• Investigators: Study Chair: Yanghai Cui, China International Neuroscience Institution

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 25, 2020
• Primary Completion (ACTUAL): August 5, 2020
• Study Completion (ACTUAL): August 5, 2020

Study Registration Dates

• First Submitted: June 8, 2020
• First Submitted That Met QC Criteria: June 20, 2020
• First Posted (ACTUAL): June 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 10, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anesthetics, Inhalation; Propofol; Sevoflurane; Sufentanil
• Other Study ID Numbers: CINI-AD-20205-19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No