Condition category
Surgery
Date applied
30/12/2009
Date assigned
16/03/2010
Last edited
25/05/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ralph Stuttmann

ORCID ID

Contact details

Mersburgerstraße 165
Halle ( Saale)
06112
Germany
ralph.stuttmann@bergmannstrost.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

23/2002

Study information

Scientific title

A single centre randomised controlled investigative study into the recovery index, attentiveness and state of memory after xenon or isoflurane anaesthesia

Acronym

Study hypothesis

The aim of the study was to evaluate the efficacy of two balanced anaesthetic regimens with respect to recovery of early post-operative cognitive function at the day of operation (assessed as attentiveness and memory; this was the primary criterion) and emergence profile (assessed as the recovery index; this was the secondary criterion). The hypothesis was primarily that patients have a significantly higher status of attentiveness and memory 1 and 3 hours after inhalation anaesthesia with xenon compared to isoflurane anaesthesia, and that patients reach their pre-operative level of cognitive function within 3 hours after extubation. The second hypotheses was that the time to wake up from the anaesthetic was predicted to be shorter following xenon than following isoflurane.

Ethics approval

Ethics Committee of the University Witten/Herdecke approved on the 11th September 2002 (ref: 23/2002). Patient insurance by Winterthur International (ref: DE 00020283-LI-02A-715).

Study design

Single centre single blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Post-operative cognitive function

Intervention

ASA I and II patients undergoing both long and short surgical interventions were randomised to receive either general anaesthesia with xenon or general anaesthesia with isoflurane. The inhalational anaesthesia was carried out following standard procedures using appropriate equipment.

Patients were randomised in blocks of 4 - 8 patients in order to balance the groups. The varying size of blocks was to counteract the differing frequencies of the operations and also any influence of duration and invasiveness of the operations. A total of 61 patients who met the pre-defined inclusion and exclusion criteria were randomised either to receive xenon in oxygen (Xenon group, n = 31) or isoflurane in stickoxydal (Isoflurane group, n = 30).

Intervention type

Drug

Phase

Not Applicable

Drug names

Xenon, isoflurane

Primary outcome measures

Syndrome Short Test

Secondary outcome measures

1. Recovery Index
2. Aldrete Score

Overall trial start date

01/06/2003

Overall trial end date

31/05/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy American Society of Anaesthesiologists (ASA) grade I and II patients
2. Aged over 18 years of age, either sex
3. Scheduled for four different types of elective surgery. The types of surgery were:
3.1. Visceral surgical strumectomy
3.2. Augmentation or reduction mammaplasty
3.3. Liposuction in obese patients
3.4. Knee arthroscopy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

61

Participant exclusion criteria

1. Patients with ASA classification grade greater than 2
2. Aged less than 18 years
3. Emergency surgery
4. Alcohol or drug abuse
5. Organ dysfunction of liver, kidney or pulmonary system
6. Diabetes

Recruitment start date

01/06/2003

Recruitment end date

31/05/2005

Locations

Countries of recruitment

Germany

Trial participating centre

Mersburgerstraße 165
Halle ( Saale)
06112
Germany

Sponsor information

Organisation

BG-Kliniken Bergmannstrost (Germany)

Sponsor details

c/o PD Dr. med. Ralph Stuttmann
Merseburgerstraße 165
Halle
06112
Germany
ralph.stuttmann@bergmannstrost.com

Sponsor type

Hospital/treatment centre

Website

http://www.bergmannstrost.com

Funders

Funder type

Industry

Funder name

Messer Griesheim/AIR LIQUIDE Medical GmbH (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20459661

Publication citations

  1. Results

    Stuttmann R, Jakubetz J, Schultz K, Schäfer C, Langer S, Ullmann U, Hilbert P, Recovery index, attentiveness and state of memory after xenon or isoflurane anaesthesia: a randomized controlled trial., BMC Anesthesiol, 2010, 10, 5, doi: 10.1186/1471-2253-10-5.

Additional files

Editorial Notes