General Anesthesia, Urinary Surgery
Conditions
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.
Interventions
DRUGPropofol
5 mg kg-1 h-1 propofol was pumped continuously after endotracheal intubation.
DRUG1% Sevoflurane
add 1% end-tidal sevoflurane 20 minutes after endotracheal intubation.
DRUG1% Sevoflurane continue
1% sevoflurane continued to maintain anesthesia after endotracheal intubation.
DRUGSufentanil
0.01 μ g kg-1 min-1 sufentanil were pumped continuously at maintain phase
DRUG2% Sevoflurane
2% sevoflurane continued to maintain anesthesia after endotracheal intubation.
DRUGPropofol half
2.5 mg kg-1 h-1 propofol was pumped continuously after endotracheal intubation.
Sponsors
China International Neuroscience Institution
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extubation Duration(ED) | Up to 24 hours | the extubation Duration (ED) was calculated as the time from the end of anesthesia to extubation of the LMA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The heart rate | From entering the operation room until the discharge from the operation room, assessed up to 12 hours | The heart rate |
| Length of PACU | Up to 24 hours | Length of PACU (Post-anesthesia care unit): From entering the PACU to discharge from the PACU |
| qNOX | From entering the operation room until the discharge from the operation room, assessed up to 12 hours | 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. |
| Bis | From entering the operation room until the discharge from the operation room, assessed up to 12 hours | Bispectral index,Bis 50-80 means appropriate Sedation depth |
| Blood pressure | From entering the operation room until the discharge from the operation room, assessed up to 12 hours | measuring Systolic, Diastolic and Mean Blood Pressure |
Countries
China
Outcome results
None listed