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Sponsored by: |
University of Heidelberg |
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Information provided by: | University of Heidelberg |
ClinicalTrials.gov Identifier: | NCT00176098 |
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 |
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Cataract |
Procedure: Hypnoanalgesia; Hypnotic shielding |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Correlation of Stress, Patient Comfort and Safety to Bispectral Index in Patients Under Hypnosis for Cataract Surgery |
Ages Eligible for Study: | 10 Years to 95 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Study Chair: | Thomas Frietsch, MD, PhD | Dept. of Anesthesiology and Critical Care Medicine, Faculty of Clinical Medicine Mannheim, University of Heidelberg |
Study ID Numbers: | TF-KliMa-2005-1 |
Study First Received: | September 12, 2005 |
Last Updated: | February 6, 2006 |
ClinicalTrials.gov Identifier: | NCT00176098 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Cataract surgery Hypnosis C11.510.245 F04.754.424.771 Suggestion |
Eye Diseases Cataract Stress Lens Diseases |