A phase III, multicenter, open-label, randomized, comparative study evaluating the effect of sevoflurane versus isoflurane on the maintenance of anesthesia in adult ASA class I, II, and III inpatients

Christina Campbell, Magna Andreen, Michael F. Battito, Enrico M. Camporesi, Michael E. Goldberg, R. M. Grounds, Jonny Hobbhahn, Philip Lumb, James M. Murray, Daneshvari R. Solanki, Stephen O. Heard, Pierre Coriat

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

Study Objective: To compare the clinical efficacy and safety of sevoflurane and isoflurane when used for the maintenance of anesthesia in adult ASA I, II, and III inpatients undergoing surgical procedures of at least 1 hour's duration. Design: Phase III, randomized, open-label clinical trial. Setting: 12 international surgical units. Patients: 555 consenting inpatients undergoing surgeries of intermediate duration. Interventions: Subjects received either sevoflurane (n = 272) or isoflurane (n = 283) as their primary anesthetic drug, each administered in nitrous oxide (N2O) (up to 70%) and oxygen (O2) after an intravenous induction using thiopental and low-dose fentanyl. The concentration of volatile drug was kept relatively constant but some titration in response to clinical variables was permitted. Comparison of efficacy was based on observations made of the rapidity and ease of recovery from anesthesia and the frequency of untoward effects for the duration of anesthesia to the return of orientation. Safety was evaluated by monitoring adverse experiences, hematologic and non-laboratory testing, and physical assessments. In 25% of patients (all patients in both treatment groups at selected investigational sites), plasma inorganic fluoride concentrations were determined preoperatively, every 2 hours during maintenance, at the end of anesthesia, and at 1, 2, 4, 8, 12, 24, 48, and 72 hours postoperatively. Measurements and Main Results: Emergence, response to commands, orientation, and the first request for postoperative analgesia were all more rapid following discontinuation of sevoflurane than following discontinuation of isoflurane (sevoflurane, 11.0 ± 0.6, 12.8 ± 0.7, 17.2 ± 0.9, 46.1 ± 3.0 minutes, respectively, versus isoflurane, 16.4 ± 0.6, 18.4 ± 0.7, 24.7 ± 0.9, 55.4 ± 3.2 minutes). The incidence of adverse experiences was similar for sevoflurane and isoflurane patients. Forty-eight percent of patients in the sevoflurane group had no untoward effects versus 39% in the isoflurane group. Three patients who received sevoflurane had serum inorganic fluoride levels 50 μM/L on greater though standard tests indicated no evidence of associated renal dysfunction. Conclusion: Sevoflurane anesthesia, as compared with isoflurane, may be advantageous in providing a smoother clinical course with a more rapid recovery.

Original languageEnglish (US)
Pages (from-to)557-563
Number of pages7
JournalJournal of Clinical Anesthesia
Volume8
Issue number7
DOIs
StatePublished - Nov 1996

Fingerprint

Isoflurane
Inpatients
Anesthesia
Maintenance
Fluorides
Safety
Thiopental
sevoflurane
Nitrous Oxide
Fentanyl
Analgesia
Anesthetics
Clinical Trials
Oxygen
Kidney
Incidence
Serum
Pharmaceutical Preparations

Keywords

  • Anesthetics, gases
  • anesthetics, volatile
  • isoflurane, sevoflurane
  • nitrous-oxide

ASJC Scopus subject areas

  • Anesthesiology and Pain Medicine

Cite this

A phase III, multicenter, open-label, randomized, comparative study evaluating the effect of sevoflurane versus isoflurane on the maintenance of anesthesia in adult ASA class I, II, and III inpatients. / Campbell, Christina; Andreen, Magna; Battito, Michael F.; Camporesi, Enrico M.; Goldberg, Michael E.; Grounds, R. M.; Hobbhahn, Jonny; Lumb, Philip; Murray, James M.; Solanki, Daneshvari R.; Heard, Stephen O.; Coriat, Pierre.

In: Journal of Clinical Anesthesia, Vol. 8, No. 7, 11.1996, p. 557-563.

Research output: Contribution to journalArticle

Campbell, C, Andreen, M, Battito, MF, Camporesi, EM, Goldberg, ME, Grounds, RM, Hobbhahn, J, Lumb, P, Murray, JM, Solanki, DR, Heard, SO & Coriat, P 1996, 'A phase III, multicenter, open-label, randomized, comparative study evaluating the effect of sevoflurane versus isoflurane on the maintenance of anesthesia in adult ASA class I, II, and III inpatients', Journal of Clinical Anesthesia, vol. 8, no. 7, pp. 557-563. https://doi.org/10.1016/S0952-8180(96)00132-8
Campbell, Christina ; Andreen, Magna ; Battito, Michael F. ; Camporesi, Enrico M. ; Goldberg, Michael E. ; Grounds, R. M. ; Hobbhahn, Jonny ; Lumb, Philip ; Murray, James M. ; Solanki, Daneshvari R. ; Heard, Stephen O. ; Coriat, Pierre. / A phase III, multicenter, open-label, randomized, comparative study evaluating the effect of sevoflurane versus isoflurane on the maintenance of anesthesia in adult ASA class I, II, and III inpatients. In: Journal of Clinical Anesthesia. 1996 ; Vol. 8, No. 7. pp. 557-563.
@article{63d6f9ea239f440b871180ae090899ad,
title = "A phase III, multicenter, open-label, randomized, comparative study evaluating the effect of sevoflurane versus isoflurane on the maintenance of anesthesia in adult ASA class I, II, and III inpatients",
abstract = "Study Objective: To compare the clinical efficacy and safety of sevoflurane and isoflurane when used for the maintenance of anesthesia in adult ASA I, II, and III inpatients undergoing surgical procedures of at least 1 hour's duration. Design: Phase III, randomized, open-label clinical trial. Setting: 12 international surgical units. Patients: 555 consenting inpatients undergoing surgeries of intermediate duration. Interventions: Subjects received either sevoflurane (n = 272) or isoflurane (n = 283) as their primary anesthetic drug, each administered in nitrous oxide (N2O) (up to 70{\%}) and oxygen (O2) after an intravenous induction using thiopental and low-dose fentanyl. The concentration of volatile drug was kept relatively constant but some titration in response to clinical variables was permitted. Comparison of efficacy was based on observations made of the rapidity and ease of recovery from anesthesia and the frequency of untoward effects for the duration of anesthesia to the return of orientation. Safety was evaluated by monitoring adverse experiences, hematologic and non-laboratory testing, and physical assessments. In 25{\%} of patients (all patients in both treatment groups at selected investigational sites), plasma inorganic fluoride concentrations were determined preoperatively, every 2 hours during maintenance, at the end of anesthesia, and at 1, 2, 4, 8, 12, 24, 48, and 72 hours postoperatively. Measurements and Main Results: Emergence, response to commands, orientation, and the first request for postoperative analgesia were all more rapid following discontinuation of sevoflurane than following discontinuation of isoflurane (sevoflurane, 11.0 ± 0.6, 12.8 ± 0.7, 17.2 ± 0.9, 46.1 ± 3.0 minutes, respectively, versus isoflurane, 16.4 ± 0.6, 18.4 ± 0.7, 24.7 ± 0.9, 55.4 ± 3.2 minutes). The incidence of adverse experiences was similar for sevoflurane and isoflurane patients. Forty-eight percent of patients in the sevoflurane group had no untoward effects versus 39{\%} in the isoflurane group. Three patients who received sevoflurane had serum inorganic fluoride levels 50 μM/L on greater though standard tests indicated no evidence of associated renal dysfunction. Conclusion: Sevoflurane anesthesia, as compared with isoflurane, may be advantageous in providing a smoother clinical course with a more rapid recovery.",
keywords = "Anesthetics, gases, anesthetics, volatile, isoflurane, sevoflurane, nitrous-oxide",
author = "Christina Campbell and Magna Andreen and Battito, {Michael F.} and Camporesi, {Enrico M.} and Goldberg, {Michael E.} and Grounds, {R. M.} and Jonny Hobbhahn and Philip Lumb and Murray, {James M.} and Solanki, {Daneshvari R.} and Heard, {Stephen O.} and Pierre Coriat",
year = "1996",
month = "11",
doi = "10.1016/S0952-8180(96)00132-8",
language = "English (US)",
volume = "8",
pages = "557--563",
journal = "Journal of Clinical Anesthesia",
issn = "0952-8180",
publisher = "Elsevier Inc.",
number = "7",

}

TY - JOUR

T1 - A phase III, multicenter, open-label, randomized, comparative study evaluating the effect of sevoflurane versus isoflurane on the maintenance of anesthesia in adult ASA class I, II, and III inpatients

AU - Campbell, Christina

AU - Andreen, Magna

AU - Battito, Michael F.

AU - Camporesi, Enrico M.

AU - Goldberg, Michael E.

AU - Grounds, R. M.

AU - Hobbhahn, Jonny

AU - Lumb, Philip

AU - Murray, James M.

AU - Solanki, Daneshvari R.

AU - Heard, Stephen O.

AU - Coriat, Pierre

PY - 1996/11

Y1 - 1996/11

N2 - Study Objective: To compare the clinical efficacy and safety of sevoflurane and isoflurane when used for the maintenance of anesthesia in adult ASA I, II, and III inpatients undergoing surgical procedures of at least 1 hour's duration. Design: Phase III, randomized, open-label clinical trial. Setting: 12 international surgical units. Patients: 555 consenting inpatients undergoing surgeries of intermediate duration. Interventions: Subjects received either sevoflurane (n = 272) or isoflurane (n = 283) as their primary anesthetic drug, each administered in nitrous oxide (N2O) (up to 70%) and oxygen (O2) after an intravenous induction using thiopental and low-dose fentanyl. The concentration of volatile drug was kept relatively constant but some titration in response to clinical variables was permitted. Comparison of efficacy was based on observations made of the rapidity and ease of recovery from anesthesia and the frequency of untoward effects for the duration of anesthesia to the return of orientation. Safety was evaluated by monitoring adverse experiences, hematologic and non-laboratory testing, and physical assessments. In 25% of patients (all patients in both treatment groups at selected investigational sites), plasma inorganic fluoride concentrations were determined preoperatively, every 2 hours during maintenance, at the end of anesthesia, and at 1, 2, 4, 8, 12, 24, 48, and 72 hours postoperatively. Measurements and Main Results: Emergence, response to commands, orientation, and the first request for postoperative analgesia were all more rapid following discontinuation of sevoflurane than following discontinuation of isoflurane (sevoflurane, 11.0 ± 0.6, 12.8 ± 0.7, 17.2 ± 0.9, 46.1 ± 3.0 minutes, respectively, versus isoflurane, 16.4 ± 0.6, 18.4 ± 0.7, 24.7 ± 0.9, 55.4 ± 3.2 minutes). The incidence of adverse experiences was similar for sevoflurane and isoflurane patients. Forty-eight percent of patients in the sevoflurane group had no untoward effects versus 39% in the isoflurane group. Three patients who received sevoflurane had serum inorganic fluoride levels 50 μM/L on greater though standard tests indicated no evidence of associated renal dysfunction. Conclusion: Sevoflurane anesthesia, as compared with isoflurane, may be advantageous in providing a smoother clinical course with a more rapid recovery.

AB - Study Objective: To compare the clinical efficacy and safety of sevoflurane and isoflurane when used for the maintenance of anesthesia in adult ASA I, II, and III inpatients undergoing surgical procedures of at least 1 hour's duration. Design: Phase III, randomized, open-label clinical trial. Setting: 12 international surgical units. Patients: 555 consenting inpatients undergoing surgeries of intermediate duration. Interventions: Subjects received either sevoflurane (n = 272) or isoflurane (n = 283) as their primary anesthetic drug, each administered in nitrous oxide (N2O) (up to 70%) and oxygen (O2) after an intravenous induction using thiopental and low-dose fentanyl. The concentration of volatile drug was kept relatively constant but some titration in response to clinical variables was permitted. Comparison of efficacy was based on observations made of the rapidity and ease of recovery from anesthesia and the frequency of untoward effects for the duration of anesthesia to the return of orientation. Safety was evaluated by monitoring adverse experiences, hematologic and non-laboratory testing, and physical assessments. In 25% of patients (all patients in both treatment groups at selected investigational sites), plasma inorganic fluoride concentrations were determined preoperatively, every 2 hours during maintenance, at the end of anesthesia, and at 1, 2, 4, 8, 12, 24, 48, and 72 hours postoperatively. Measurements and Main Results: Emergence, response to commands, orientation, and the first request for postoperative analgesia were all more rapid following discontinuation of sevoflurane than following discontinuation of isoflurane (sevoflurane, 11.0 ± 0.6, 12.8 ± 0.7, 17.2 ± 0.9, 46.1 ± 3.0 minutes, respectively, versus isoflurane, 16.4 ± 0.6, 18.4 ± 0.7, 24.7 ± 0.9, 55.4 ± 3.2 minutes). The incidence of adverse experiences was similar for sevoflurane and isoflurane patients. Forty-eight percent of patients in the sevoflurane group had no untoward effects versus 39% in the isoflurane group. Three patients who received sevoflurane had serum inorganic fluoride levels 50 μM/L on greater though standard tests indicated no evidence of associated renal dysfunction. Conclusion: Sevoflurane anesthesia, as compared with isoflurane, may be advantageous in providing a smoother clinical course with a more rapid recovery.

KW - Anesthetics, gases

KW - anesthetics, volatile

KW - isoflurane, sevoflurane

KW - nitrous-oxide

UR - http://www.scopus.com/inward/record.url?scp=10244263490&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=10244263490&partnerID=8YFLogxK

U2 - 10.1016/S0952-8180(96)00132-8

DO - 10.1016/S0952-8180(96)00132-8

M3 - Article

C2 - 8910177

AN - SCOPUS:10244263490

VL - 8

SP - 557

EP - 563

JO - Journal of Clinical Anesthesia

JF - Journal of Clinical Anesthesia

SN - 0952-8180

IS - 7

ER -