Phase 4
N=334
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
Elective Laparoscopic Surgery
Bottom Line
View on ClinicalTrials.gov: NCT01191476 ↗Enrolled (actual)
334
Serious AEs
0.0%
Results posted
Jul 2012
Primary outcome: Primary: Cost of Volatile Induction and Maintenance Anesthesia (VIMA) With Sevoflurane, Total Intravenous Anesthesia (TIVA) With Propofol, or Intravenous Induction With Propofol and Inhalational Maintenance With Sevoflurane — 380.78; 548.52; 269.40 Yuan
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sevoflurane Inhalational Induction and Maintenance (Drug); Propofol Target Controlled Infusion for Induction and Maintenance (Drug); Propofol Target Controlled Infusion for Induction and Sevoflurane Inhalation for Maintenance (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cost of Volatile Induction and Maintenance Anesthesia (VIMA) With Sevoflurane, Total Intravenous Anesthesia (TIVA) With Propofol, or Intravenous Induction With Propofol and Inhalational Maintenance With Sevoflurane |
380.78; 548.52; 269.40 | — |
| SECONDARY Time to Loss of Consciousness |
48.54; 100.32; 68.76 | — |
| SECONDARY Time to Eye Opening |
8.38; 9.79; 8.69 | — |
| SECONDARY Time to Extubation |
9.69; 11.32; 9.79 | — |
| SECONDARY Time to Orientation |
13.97; 17.64; 14.95 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Men or women, aged from 18 to 65
- ASA (American Society of Anesthesiologists) physical status (a requirement of the subject's physical status): I or II
- Body mass index (weight/height^2) from 16 to 30 kg/m^2
- Elective laparoscopic surgery requiring general anesthesia managed with endotracheal intubation
- Duration of anesthesia use will be greater than or equal to 1 hour, but less than 3 hours in length.
Exclusion Criteria
- Hypersensitivity or unusual response to any halogenated anesthetics.
- History of significant cardiovascular, pulmonary, hepatic, renal, central nervous system or muscular disease.
- Pre-operative cognitive dysfunction or disabling neuropsychiatric disorders.
- Need for emergency surgery or surgery requiring additional regional anesthetic techniques.
- Need for intracranial surgery, cardio-surgery or thoracic surgery.
- Subjects inability to cooperate with the anesthetist before administration of the anesthetic agent.
- Personal or familial history of malignant hyperthermia.
- Females who are either pregnant or breast feeding.
Data sourced from ClinicalTrials.gov (NCT01191476). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.