Depth of Hypnosis and Postoperative Nausea and Vomiting During Xenon Anaesthesia

NCT00793663 | Completed Phase 4

• 5 other identifiers: ALS-8-08-A-401EudraCT-number:2008-004132-20Protocol version:Version V3; Date: 20.10.2008
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is ad 1) to measure the depth of hypnosis as assessed by BIS and cAAI during an average general anesthesia with xenon or sevoflurane and to establish a reliable monitoring system for measuring and documenting the actual depth of hypnosis for the volatile anesthetics investigated. Ad 2) the question is to be answered whether 4 mg dexamethasone i.v. is an effective prophylactic treatment against postoperative nausea and vomiting in case of xenon or sevoflurane anesthesia. Ad 3) it serves to gain evidence about the (non-)effectiveness and kinetics of ondansetron as antiemetic remedy after xenon or sevoflurane anesthesia.

Conditions

Anaesthetics Gases, Xenon; Anaesthetics Volatile, Sevoflurane; Depth of Anaesthesia; Postoperative Nausea; Postoperative Vomiting

Keywords

Xenon; Sevoflurane; Postoperative Nausea and vomiting; Depth of anaesthesia

Outcome Measures

Primary Outcomes (3)

• The average depths of hypnosis as assessed by the BIS and the cAAI between skin incision and start of closure.

  During anaesthesia

• Postoperative nausea as assessed by a verbal rating scale (VRS) ranging between 0 and 10.

  After anesthesia at 5, 10, 15, 30, 45, 60, and 90 min. At 2, 6 and 24 h after anesthesia the maximum nausea will be rated for the 30-120 min, 2-6 h, and 6-24 h interval.

• Reduction of VRS nausea immediately at 2, 5, 7.5, 10, 15, 20 and 30 min after rescue treatment administration.

  Maximum nausea will be rated at 2, 6 and 24 hours after treatment for the 30-120 min, 2-6 h and 6-24 h interval.

Secondary Outcomes (7)

• Heart rate and blood pressure

  During anesthesia

• Observer´s assessment of alertness and sedation scales

  Recovery from anesthesia

• Sensitivity and specificity characteristics for both the BIS and the cAAI.

  During anesthesia

• Awareness after anesthesia assessed by the Brice questionnaire at 2 and 24 hours after anesthesia.

  24 hours after anaesthesia

• Occurrence of postoperative vomiting and the respective time-points will be recorded. Postoperative vomiting is defined as vomiting or retching.

  24 hours postoperative

Study Arms (6)

1

EXPERIMENTAL

The effect of xenon as an anaesthetic on the depth of hypnosis.

Drug: Xenon

2

ACTIVE COMPARATOR

The effect of sevoflurane as an anesthetic on the depth of hypnosis

Drug: Sevoflurane

3

EXPERIMENTAL

Dexamethasone as prevention of postoperative nausea and vomiting after xenon or sevoflurane anesthesia

Drug: Dexamethasone

4

PLACEBO COMPARATOR

Drug: NaCl

5

EXPERIMENTAL

Ondansetron, to determine the onset-time of ondansetron when used as rescue medication for postoperative nausea and vomiting

Drug: Ondansetron

6

PLACEBO COMPARATOR

Drug: NaCl

Interventions

Xenon DRUG

Inhalational gas; maximum dose allowed: 70 % Xenon; the duration of the treatment will be defined through anesthesia-time.

Also known as: LENOXe

1

Sevoflurane DRUG

Inhalation gas; age adapted MAC-values; the duration of the treatment will be defined through anesthesia-time

Also known as: Sevorane

2

Dexamethasone DRUG

Intravenous use, 4 mg, single shot

Also known as: Fortecortin Inject

3

NaCl DRUG

Intravenous use; single shot

4

Ondansetron DRUG

Intravenous use; 4 mg; single shot

Also known as: Zofran

5

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients ≥ 18 \< 75 years
• ASA physical status I-II
• planned duration of anesthesia ≥ 60 minutes
• Apfel score ≥ 2-3
• elective (laparoscopic) surgery (abdominal, gynecological)
• women: with a highly effective contraception, defined as methods with a pearl index \< 1 (i.e. hormonal contraceptives, IUD)

You may not qualify if:

• history of hypersensitivity to any used drugs or additive components used for preparation and stabilization of the named drugs in this trial
• history or reasonable suspicion of malignant hyperthermia and/or degenerative neuromuscular disease, in the subject observed or blood relatives
• history of liver function disorders, leucocytosis and unclear fever after usage of halogenated anesthetics.
• any indisposition that may be aggravated by the use of the drugs investigated:
• liver and/or kidney function disorders
• severe acute or chronic infectious disease (i.e. viral, bacterial, fungal)
• elevated intracranial pressure
• history of gastrointestinal ulcer(s) or inflammatory bowel disease
• severe metabolic disorders
• hematoporphyria
• glaucoma
• hearing disorders
• any disease including air-filled closed cavities, such as pneumothorax, ileus
• pregnancy and lactation period
• subjects under the age of 18 years

Sponsors & Collaborators

• RWTH Aachen University: lead
• Air Liquide Santé International: collaborator

Study Sites (1)

RWTH Aachen University; Department of Anesthesiology

Aachen, D-52074, Germany

Location

Related Publications (1)

• Fahlenkamp AV, Stoppe C, Cremer J, Biener IA, Peters D, Leuchter R, Eisert A, Apfel CC, Rossaint R, Coburn M. Nausea and Vomiting following Balanced Xenon Anesthesia Compared to Sevoflurane: A Post-Hoc Explorative Analysis of a Randomized Controlled Trial. PLoS One. 2016 Apr 25;11(4):e0153807. doi: 10.1371/journal.pone.0153807. eCollection 2016.

  PMID: 27111335 DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Xenon; Sevoflurane; Dexamethasone; Ondansetron

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Noble Gases; Elements; Inorganic Chemicals; Gases; Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Rolf Rossaint, MD

  RWTH University Aachen; Department of Anesthesiology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 18, 2008
• First Posted: November 19, 2008
• Study Start: November 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: May 17, 2011

Record last verified: 2011-05

Locations

DE (1)