Phase 4
Completed 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
Source: ClinicalTrials.gov NCT01191476 ↗
Enrolled (actual)
334
Serious AEs
0.0%
Results posted
Jul 2012
Primary outcomePrimary: 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
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.
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 | — |
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. Informational only — not medical advice.