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Compare Pharmaceutical Economics and Efficacy of Sevoflurane With Low Fresh Gas Flow Balanced Anesthesia, Propofol Target Controlled Infusion Anesthesia and Propofol Induction Sevoflurane Maintenance Anesthesia

NCT ID: NCT01191476

Last Updated: 2012-07-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

336 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-05-31

Brief Summary

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This study is being performed to compare the cost of anesthetic techniques with sevoflurane (low fresh gas flow balanced anesthesia) versus propofol (target controlled infusion \[TCI\]) versus propofol induction and sevoflurane maintenance anesthesia in subjects undergoing elective laparoscopic surgery with predicted anesthesic use between 1 and 3 hour duration.

Detailed Description

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Three hundred thirty-six subjects were enrolled in this study. Two subjects, one treated with propofol for induction and maintenance and one treated with propofol for induction and sevoflurane for maintenance are not included in the study participation since no information was available for these two subjects.

Conditions

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Elective Laparoscopic Surgery

Keywords

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Sevoflurane Propofol Economics Pharmaceutical Chinese

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sevoflurane

Subjects received sevoflurane, a inhalational (volatile) anesthetic, which was administered for induction and maintenance of general anesthesia. Inhalational induction was induced via vital capacity induction at 8% and maintained at 0.8-1.5 minimum alveolar concentration (MAC).

Group Type ACTIVE_COMPARATOR

Sevoflurane Inhalational Induction and Maintenance

Intervention Type DRUG

Sevoflurane was administered at a concentration of 8% via vital capacity induction and sevoflurane 0.8-1.5 minimum alveolar concentration (MAC) with a rate of 1 L/min fresh gas flow for maintenance.

Propofol

Subjects received propofol, an intravenous (IV) anesthetic, which was administered for induction and maintenance of general anesthesia.

Group Type ACTIVE_COMPARATOR

Propofol Target Controlled Infusion for Induction and Maintenance

Intervention Type DRUG

Propofol IV 4 ug/mL was administered with target controlled infusion (TCI) for induction and propofol 3 to 6 ug/mL was administered with TCI for maintenance.

Propofol Induction and Sevoflurane Maintenance

Subjects received a bolus dose of propofol of 1.5 mg/kg administered for IV induction followed by sevoflurane at 0.8-1.5 MAC for maintenance anesthesia.

Group Type ACTIVE_COMPARATOR

Propofol Target Controlled Infusion for Induction and Sevoflurane Inhalation for Maintenance

Intervention Type DRUG

Propofol was administered as a bolus IV dose of 1.5 mg/kg for induction at a rate of 40 mg/10 seconds. During maintenance, a sevoflurane concentration of 0.8-1.5 minimal alveolar concentration (MAC) was administered at a rate of 1 L/min fresh gas flow.

Interventions

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Sevoflurane Inhalational Induction and Maintenance

Sevoflurane was administered at a concentration of 8% via vital capacity induction and sevoflurane 0.8-1.5 minimum alveolar concentration (MAC) with a rate of 1 L/min fresh gas flow for maintenance.

Intervention Type DRUG

Propofol Target Controlled Infusion for Induction and Maintenance

Propofol IV 4 ug/mL was administered with target controlled infusion (TCI) for induction and propofol 3 to 6 ug/mL was administered with TCI for maintenance.

Intervention Type DRUG

Propofol Target Controlled Infusion for Induction and Sevoflurane Inhalation for Maintenance

Propofol was administered as a bolus IV dose of 1.5 mg/kg for induction at a rate of 40 mg/10 seconds. During maintenance, a sevoflurane concentration of 0.8-1.5 minimal alveolar concentration (MAC) was administered at a rate of 1 L/min fresh gas flow.

Intervention Type DRUG

Other Intervention Names

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ABT-941 sevoflurane Ultane Sevorane Sevofrane Propofol ABT-941 sevoflurane Ultane Sevorane Sevofrane

Eligibility Criteria

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Inclusion Criteria

1. Men or women, aged from 18 to 65
2. ASA (American Society of Anesthesiologists) physical status (a requirement of the subject's physical status): I or II
3. Body mass index (weight/height\^2) from 16 to 30 kg/m\^2
4. Elective laparoscopic surgery requiring general anesthesia managed with endotracheal intubation
5. Duration of anesthesia use will be greater than or equal to 1 hour, but less than 3 hours in length.

Exclusion Criteria

1. Hypersensitivity or unusual response to any halogenated anesthetics.
2. History of significant cardiovascular, pulmonary, hepatic, renal, central nervous system or muscular disease.
3. Pre-operative cognitive dysfunction or disabling neuropsychiatric disorders.
4. Need for emergency surgery or surgery requiring additional regional anesthetic techniques.
5. Need for intracranial surgery, cardio-surgery or thoracic surgery.
6. Subjects inability to cooperate with the anesthetist before administration of the anesthetic agent.
7. Personal or familial history of malignant hyperthermia.
8. Females who are either pregnant or breast feeding.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rundo International Pharmaceutical Research & Development Co.,Ltd.

INDUSTRY

Sponsor Role collaborator

Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yue Kang, MD

Role: STUDY_DIRECTOR

Abbott

Locations

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Site Reference ID/Investigator# 41983

Beijing, , China

Site Status

Site Reference ID/Investigator# 41932

Chengdu, , China

Site Status

Site Reference ID/Investigator# 41985

Guangzhou, , China

Site Status

Site Reference ID/Investigator# 41984

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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R12-564

Identifier Type: -

Identifier Source: org_study_id