An investigative study into the recovery index, attentiveness and state of memory after xenon or isoflurane anaesthesia
| ISRCTN | ISRCTN01110844 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01110844 |
| Secondary identifying numbers | 23/2002 |
- Submission date
- 30/12/2009
- Registration date
- 16/03/2010
- Last edited
- 25/05/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ralph Stuttmann
Scientific
Scientific
Mersburgerstraße 165
Halle ( Saale)
06112
Germany
| ralph.stuttmann@bergmannstrost.com |
Study information
| Study design | Single centre single blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A single centre randomised controlled investigative study into the recovery index, attentiveness and state of memory after xenon or isoflurane anaesthesia |
| Study objectives | 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(s) | 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). |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Xenon, isoflurane |
| Primary outcome measure | Syndrome Short Test |
| Secondary outcome measures | 1. Recovery Index 2. Aldrete Score |
| Overall study start date | 01/06/2003 |
| Completion date | 31/05/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 61 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2003 |
| Date of final enrolment | 31/05/2005 |
Locations
Countries of recruitment
- Germany
Study participating centre
Mersburgerstraße 165
Halle ( Saale)
06112
Germany
06112
Germany
Sponsor information
BG-Kliniken Bergmannstrost (Germany)
Hospital/treatment centre
Hospital/treatment centre
c/o PD Dr. med. Ralph Stuttmann
Merseburgerstraße 165
Halle
06112
Germany
| ralph.stuttmann@bergmannstrost.com | |
| Website | http://www.bergmannstrost.com |
"ROR" |
https://ror.org/042g9vq32 |
Funders
Funder type
Industry
Messer Griesheim/AIR LIQUIDE Medical GmbH (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 07/05/2010 | Yes | No |
