Different Anesthesia Maintain Protocol Effect the Outcome of the Patients

General Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04443946
• Other study ID #: CINI-AD-20205-19
• Status: Completed
• Phase: Phase 4
• Start date: June 25, 2020
• Est. completion date: August 5, 2020

Study information

• Verified date: June 2020
• Source: China International Neuroscience Institution
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 5, 2020
• Est. primary completion date: August 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• General Anesthesia
• Urinary Surgery

Intervention

Drug:
• Propofol
5 mg kg-1 h-1 propofol was pumped continuously after endotracheal intubation.
• 1% Sevoflurane
add 1% end-tidal sevoflurane 20 minutes after endotracheal intubation.
• 1% Sevoflurane continue
1% sevoflurane continued to maintain anesthesia after endotracheal intubation.
• Sufentanil
0.01 µ g kg-1 min-1 sufentanil were pumped continuously at maintain phase
• 2% Sevoflurane
2% sevoflurane continued to maintain anesthesia after endotracheal intubation.
• Propofol half
2.5 mg kg-1 h-1 propofol was pumped continuously after endotracheal intubation.

Locations

Country	Name	City	State
China	Xuanwu hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China International Neuroscience Institution

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Length of PACU	Length of PACU (Post-anesthesia care unit): From entering the PACU to discharge from the PACU	Up to 24 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	The heart rate	The heart rate	From entering the operation room until the discharge from the operation room, assessed up to 12 hours