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Hypnosis for Eye Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by Heidelberg University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00176098
First Posted: September 15, 2005
Last Update Posted: February 7, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Heidelberg University
  Purpose
Perioperative stress for cataract surgery in the elderly is considerable even in the absence of pain. For these patients with a high comorbidity level, the perioperative situation comprising factors such as uncomfortable positioning, dull ambience, face cover, poor sedation, and anxiety might not only reduce intraoperative compliance but induce cardiac ischemia and hypertensive crises. Hypnosis is supposed to increase patient comfort, to shield the patient from organic stress and to improve intraoperative compliance without side effects even in old and very ill patients. In a controlled study, we, the investigators at the University of Heidelberg, compared phakoemulsification under topical anesthesia as usual (and placebo hypnosis) with either additional hypnosis or hypnoanalgesia without topical anesthesia.

Condition Intervention Phase
Cataract Procedure: Hypnoanalgesia; Hypnotic shielding Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Correlation of Stress, Patient Comfort and Safety to Bispectral Index in Patients Under Hypnosis for Cataract Surgery

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Reduction of perioperative stress
  • Improvement of patient comfort and safety

Secondary Outcome Measures:
  • Correlation of hypnotic depth with bispectral index (BIS)

Estimated Enrollment: 70
Study Start Date: September 2005
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 95 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cataract

Exclusion Criteria:

  • Uncorrected hearing disability
  • Pharmacological beta-blockade
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00176098


Contacts
Contact: Thomas Frietsch, MD, PhD +49 621 383 2903 thomas.frietsch@urz.uni-heidelberg.de
Contact: Michael Schoeler, MD +49 621 383 2415 michael.schoeler@anaes.ma.uni-heidelberg.de

Locations
Germany
Dept. of Anesthesiology and Critical Care Medicine, Faculty of Clinical Medicine Mannheim, University of Heidelberg Recruiting
Mannheim, Germany, 68167
Contact: Thomas Frietsch, MD, PhD    +49 621 383 2903    thomas.frietsch@urz.uni-heidelberg.de   
Sub-Investigator: Michael Schoeler, MD         
Sponsors and Collaborators
Heidelberg University
Investigators
Study Chair: Thomas Frietsch, MD, PhD Dept. of Anesthesiology and Critical Care Medicine, Faculty of Clinical Medicine Mannheim, University of Heidelberg
  More Information

ClinicalTrials.gov Identifier: NCT00176098     History of Changes
Other Study ID Numbers: TF-KliMa-2005-1
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: February 7, 2006
Last Verified: September 2005

Keywords provided by Heidelberg University:
Cataract surgery
Hypnosis
C11.510.245
F04.754.424.771
Suggestion

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs