Sevoflurane vs. Isoflurane for Low-Flow General Anaesthesia for Abdominal Surgery

NCT00521612 | Completed DMC

• 1 other identifier: 75736
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Two groups of patients are going to have abdominal surgery with low-flow general anaesthesia. Group A (sevoflurane group, experimental group) will use volatile anaesthetic sevoflurane. Group B (isoflurane group, control group) will use volatile anaesthetic isoflurane. It will be observed differences between volatile anaesthetic sevoflurane and volatile anaesthetic isoflurane for providing low-flow general anaesthesia for abdominal surgery. Duration of this randomised controled trial will be approximately 2 months. Estimated sample size will be 82 persons (41 in sevoflurane group and 41 in isoflurane group).

Conditions

Anaesthesia

Keywords

sevoflurane; isoflurane; anaesthesia

Outcome Measures

Primary Outcomes (1)

• Differences between volatile anaesthetic sevoflurane and volatile anaesthetic isoflurane for providing low-flow general anaesthesia for abdominal surgery.

  approximately time for this trial is about 2 months

Secondary Outcomes (1)

• Differences in awakening patients from low-flow general anaesthesia provided by sevoflurane and isoflurane.

  approximately time for this trial is about 2 months

Study Arms (2)

A

EXPERIMENTAL

Sevoflurane group, experimental group

Drug: sevoflurane

B

ACTIVE COMPARATOR

Isoflurane group, control group

Drug: isoflurane

Interventions

sevoflurane DRUG

Volatile anaesthetic sevoflurane 1 MAC (2,0 vol%) will be administer to the patients in the form of gas (via respiration). First 20 minutes of anaesthesia will be period of saturation of the body with anaesthetic sevoflurane. After 20 minutes the depth of anaesthesia will be titrated with level of anaesthetic sevoflurane. Change will be +10 % of sevoflurane MAC (0,2 vol%) for every change of signs that indicate shallow anaesthesia. Change will be -10 % of sevoflurane MAC (0,2 vol%) for every change of signs that indicate too deep anaesthesia. Measuring points will be every 5 minutes during surgery.

Also known as: Sevorane

A

isoflurane DRUG

Volatile anaesthetic isoflurane 1 MAC (1,2 vol%) will be administer to the patients in the form of gas (via respiration). First 20 minutes of anaesthesia will be period of saturation of the body with anaesthetic isoflurane. After 20 minutes the depth of anaesthesia will be titrated with level of anaesthetic isoflurane. Change will be +10 % of isoflurane MAC (0,12 vol%) for every change of signs that indicate shallow anaesthesia. Change will be -10 % of isoflurane MAC (0,12 vol%) for every change of signs that indicate too deep anaesthesia. Measuring points will be every 5 minutes during surgery.

Also known as: Forane

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Every patient who is older than 18 years and who volunteer for this randomised controled trial and give written permission for participating in this study.
• Patients ASA I or ASA II.
• Only patients who need elective abdominal surgery (not urgent surgery).
• Patient body mass between 60 and 100 kg.

You may not qualify if:

• Patients younger than 18 years
• Patients ASA III and higher
• Patients who need urgent abdominal surgery
• Patients allergic to anaesthetics
• Pregnant women
• Patients with neuromuscular diseases; and
• Persons with epidural analgesia catheter.

Sponsors & Collaborators

• General Hospital Dubrovnik: lead

Study Sites (1)

General Hospital Dubrovnik

Dubrovnik, 20 000, Croatia

Location

Related Publications (5)

• Mahajan VA, Ni Chonghaile M, Bokhari SA, Harte BH, Flynn NM, Laffey JG. Recovery of older patients undergoing ambulatory anaesthesia with isoflurane or sevoflurane. Eur J Anaesthesiol. 2007 Jun;24(6):505-10. doi: 10.1017/S0265021506001980. Epub 2007 Jan 4.

  PMID: 17202009 BACKGROUND

• Venkatesh BG, Mehta Y, Kumar A, Trehan N. Comparison of sevoflurane and isoflurane in OPCAB surgery. Ann Card Anaesth. 2007 Jan;10(1):46-50. doi: 10.4103/0971-9784.37924.

  PMID: 17455408 BACKGROUND

• Seitsonen ER, Yli-Hankala AM, Korttila KT. Similar recovery from bispectral index-titrated isoflurane and sevoflurane anesthesia after outpatient gynecological surgery. J Clin Anesth. 2006 Jun;18(4):272-9. doi: 10.1016/j.jclinane.2005.12.005.

  PMID: 16797429 BACKGROUND

• Sakai EM, Connolly LA, Klauck JA. Inhalation anesthesiology and volatile liquid anesthetics: focus on isoflurane, desflurane, and sevoflurane. Pharmacotherapy. 2005 Dec;25(12):1773-88. doi: 10.1592/phco.2005.25.12.1773.

  PMID: 16305297 BACKGROUND

• Nakayama M, Kanaya N, Edanaga M, Namiki A. Hemodynamic and bispectral index responses to tracheal intubation during isoflurane or sevoflurane anesthesia. J Anesth. 2003;17(4):223-6. doi: 10.1007/s00540-003-0186-4.

  PMID: 14625708 BACKGROUND

Related Links

• Web site of General Hospital Dubrovnik

MeSH Terms

Interventions

Sevoflurane; Isoflurane

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Ante Crncevic, MD, MSc.

  specialist in anaesthesiology and intensive care medicine

  PRINCIPAL INVESTIGATOR

• Zoran Dogas, MD, PhD.

  Professor of Neuroscience, University of Split, School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 27, 2007
• First Posted: August 28, 2007
• Study Start: September 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: January 7, 2008

Record last verified: 2007-12

Locations

CR (1)