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

Abbott

Status and phase: Completed; Phase 4

Conditions: Elective Laparoscopic Surgery

Treatments: Drug: Propofol Target Controlled Infusion for Induction and Sevoflurane Inhalation for Maintenance; Drug: Sevoflurane Inhalational Induction and Maintenance; Drug: Propofol Target Controlled Infusion for Induction and Maintenance

Study type: Interventional

Funder types: Industry

Identifiers

NCT01191476

R12-564

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 336 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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336 participants in 3 patient groups

Sevoflurane

Active Comparator group

Description:

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).

Treatment:

Drug: Sevoflurane Inhalational Induction and Maintenance

Propofol

Active Comparator group

Description:

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

Treatment:

Drug: Propofol Target Controlled Infusion for Induction and Maintenance

Propofol Induction and Sevoflurane Maintenance

Active Comparator group

Description:

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.

Treatment:

Drug: Propofol Target Controlled Infusion for Induction and Sevoflurane Inhalation for Maintenance