Trial Outcomes & Findings for Clinical Practice of Inhalation Anesthesia With Sevoflurane in China (NCT NCT01715857)

NCT ID: NCT01715857

Last Updated: 2014-08-19

Results Overview

Anesthesiologist satisfaction with the anesthesia was recorded by the anesthesiologist at the end of the operation using a NAS from 0 (not satisfied at all) to 10 (completely satisfied). The satisfaction of induction, maintenance, and emergence accounts for 20%, 50%, and 30% of the score, respectively.

• Recruitment status: COMPLETED
• Target enrollment: 4100 participants
• Primary outcome timeframe: End of surgery
• Results posted on: 2014-08-19

Participant Flow

Participant milestones

Measure	Chinese Patients Requiring Surgery With Sevoflurane Anesthesia Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
Overall Study STARTED	4100
Overall Study COMPLETED	4004
Overall Study NOT COMPLETED	96

Reasons for withdrawal

Measure	Chinese Patients Requiring Surgery With Sevoflurane Anesthesia Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
Overall Study Did Not Meet Eligibility Criteria	96

Baseline Characteristics

Clinical Practice of Inhalation Anesthesia With Sevoflurane in China

Baseline characteristics by cohort

Measure	Chinese Patients Requiring Surgery With Sevoflurane Anesthesia n=4004 Participants Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
Age, Continuous	45.54 years STANDARD_DEVIATION 12.57 • n=5 Participants
Sex: Female, Male Female	2720 Participants n=5 Participants
Sex: Female, Male Male	1284 Participants n=5 Participants
American Society of Anesthesiologist (ASA) Physical Status ASA Physical Status I	47.33 percentage of participants n=5 Participants
American Society of Anesthesiologist (ASA) Physical Status ASA Physical Status II	49.18 percentage of participants n=5 Participants
American Society of Anesthesiologist (ASA) Physical Status ASA Physical Status III	3.50 percentage of participants n=5 Participants
American Society of Anesthesiologist (ASA) Physical Status ASA Physical Status IV	0 percentage of participants n=5 Participants
American Society of Anesthesiologist (ASA) Physical Status ASA Physical Status V	0 percentage of participants n=5 Participants
Type of Surgery General Surgery	55.09 percentage of participants n=5 Participants
Type of Surgery Gynecologic Surgery	28.17 percentage of participants n=5 Participants
Type of Surgery Orthopedic Surgery	16.73 percentage of participants n=5 Participants
Body Weight	62.19 kilograms STANDARD_DEVIATION 10.96 • n=5 Participants

PRIMARY outcome

Timeframe: End of surgery

Anesthesiologist satisfaction with the anesthesia was recorded by the anesthesiologist at the end of the operation using a NAS from 0 (not satisfied at all) to 10 (completely satisfied). The satisfaction of induction, maintenance, and emergence accounts for 20%, 50%, and 30% of the score, respectively.

Outcome measures

Measure	Chinese Patients Requiring Surgery With Sevoflurane Anesthesia n=4004 Participants Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
Anesthesiologist Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS)	9.14 scores on a scale Standard Deviation 0.85

PRIMARY outcome

Timeframe: 24 hours after end of surgery

Population: All participants who received study drug and with available data.

Participant satisfaction with the anesthesia recorded approximately 24 hours after the end of the operation using a NAS from 0 (not satisfied at all) to 10 (completely satisfied).

Outcome measures

Measure	Chinese Patients Requiring Surgery With Sevoflurane Anesthesia n=4004 Participants Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
Participant Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS)	9.21 scores on a scale Standard Deviation 0.91

SECONDARY outcome

Timeframe: From cessation of sevoflurane administration until the participant opened their eyes, up to 80 minutes

Population: All participants who received study drug and with available data.

After cessation of anesthesia, the investigators lightly tapped on the participant's forehead or shoulder and asked the participant to open their eyes. This process was repeated approximately every minute until eye opening occurred.

Outcome measures

Measure	Chinese Patients Requiring Surgery With Sevoflurane Anesthesia n=3982 Participants Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
Time to Eye Opening	17.30 minutes Standard Deviation 11.56

SECONDARY outcome

Timeframe: From cessation of sevoflurane administration until tracheal extubation occurred, up to 80 minutes

Population: All participants who received study drug and with available data.

Time to extubation was measured from the time sevoflurane administration had stopped until tracheal extubation or laryngeal mask airway (LMA) removal occurred.

Outcome measures

Measure	Chinese Patients Requiring Surgery With Sevoflurane Anesthesia n=3981 Participants Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
Time to Extubation	20.28 minutes Standard Deviation 13.50

SECONDARY outcome

Timeframe: Anesthetic duration between 1 to 5 hours

Population: All participants who received study drug and with available data.

Cost of anesthetics is the sum of the cost of sevoflurane and other anesthetics including narcotics and muscle relaxants. Cost of sevoflurane = unit price of sevoflurane multiplied by the used volume of sevoflurane. Cost of other anesthetics = unit price of anesthetics multiplied by the total volume of anesthetics in the ampoule.

Outcome measures

Measure	Chinese Patients Requiring Surgery With Sevoflurane Anesthesia n=3874 Participants Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
Cost of Anesthetics Including Sevoflurane (Yuan Renminbi [RMB]/Hour)	249.79 Yuan renminbi [RMB]/hour Standard Deviation 168.01

SECONDARY outcome

Timeframe: During maintenance (up to 5 hours)

Population: All participants who received study drug and with available data.

Non-compliance of sevoflurane end tidal concentration was defined as the percentage of time points for the maintenance period (excluding washout phase) that were below the sevoflurane end tidal concentration boundary of 0.6 minimal alveolar concentration (MAC) based on the Consensus. A higher percentage indicates a higher degree of non-compliance.

Outcome measures

Measure	Chinese Patients Requiring Surgery With Sevoflurane Anesthesia n=44374 Timepoints for Maintenance Period Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
Non-compliance of Sevoflurane End Tidal Concentration Following the Consensus	17.82 percentage of timepoints

SECONDARY outcome

Timeframe: During maintenance (up to 5 hours)

Population: All participants who received study drug and with available data.

Non-compliance of sevoflurane vaporizer setting was defined as the percentage of time points for the maintenance period outside the range of 1.0 - 1.5 minimal alveolar concentration (MAC) during the maintenance period (excluding washout phase) based on the Consensus. A higher percentage indicates a higher degree of non-compliance.

Outcome measures

Measure	Chinese Patients Requiring Surgery With Sevoflurane Anesthesia n=54454 Timepoints During Maintenance Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
Non-compliance of Sevoflurane Vaporizer Setting Following the Consensus	42.31 percentage of timepoints

Adverse Events

Chinese Patients Requiring Surgery With Sevoflurane Anesthesia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Global Medical Services

AbbVie (prior sponsor, Abbott)

Phone: 800-633-9110

Results disclosure agreements

• Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
• Publication restrictions are in place

Restriction type: OTHER