NCT00176098

Brief Summary

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

February 7, 2006

Status Verified

September 1, 2005

First QC Date

September 12, 2005

Last Update Submit

February 6, 2006

Conditions

Cataract

Keywords

Cataract surgeryHypnosisC11.510.245F04.754.424.771Suggestion

Outcome Measures

Primary Outcomes (2)

  • Reduction of perioperative stress

  • Improvement of patient comfort and safety

Secondary Outcomes (1)

  • Correlation of hypnotic depth with bispectral index (BIS)

Interventions

Hypnoanalgesia; Hypnotic shieldingPROCEDURE

Eligibility Criteria

Age10 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Cataract

You may not qualify if:

  • Uncorrected hearing disability
  • Pharmacological beta-blockade

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Anesthesiology and Critical Care Medicine, Faculty of Clinical Medicine Mannheim, University of Heidelberg

Mannheim, 68167, Germany

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Thomas Frietsch, MD, PhD

    Dept. of Anesthesiology and Critical Care Medicine, Faculty of Clinical Medicine Mannheim, University of Heidelberg

    STUDY CHAIR

Central Study Contacts

Thomas Frietsch, MD, PhD

CONTACT

+49 621 383 2903thomas.frietsch@urz.uni-heidelberg.de

Michael Schoeler, MD

CONTACT

+49 621 383 2415michael.schoeler@anaes.ma.uni-heidelberg.de

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

September 1, 2005

Last Updated

February 7, 2006

Record last verified: 2005-09

Locations

DE(1)