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| Sponsor: | Soroka University Medical Center |
|---|---|
| Collaborator: |
Ben-Gurion University of the Negev |
| Information provided by: | Soroka University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00320892 |
Purpose
Dying patients are often unable to clear secretions from their large airways, resulting in noisy breathing usually described as "death rattle." While there is no evidence that patients find this condition disturbing, the noises may be disturbing to the patient's visitors and caregivers who may fear that the patient is choking to death.
In Israel none of the pharmaceutical drugs listed in the literature exist. Thus, Atropine drops which have been noted in the literature as being used, though according to our knowledge no evidence of clinical trials using sublingual Atropine were conducted.
The study is designed as a randomly controlled, double blind crossover trial. The patient will serve as control for himself, as crossover between placebo and drug (randomly chosen) will take place. The administrator of the drug will be blinded to the medication, each time randomly beginning with a different drug (placebo or Atropine).
We will evaluate Atropine Sulphate 1% ophthalmic drops effect on 33 patients using a noise score scale of 0-3. Noise scores will be taken at the start; 30 min after drug/placebo administration and every hour thereafter. After 4-hours crossover will take place and evaluation will follow the same protocol.
| Condition | Intervention |
|---|---|
|
Noise Death |
Drug: Atropine Sulphate 1% ophthalmic drops |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
-
Contacts and Locations| Contact: Pesach Shvartzman, MD | 972-8-6477429 | spesah@bgu.ac.il |
| Contact: Valentina Semionov, MD | 972-8-6477436 | : valsem2002@yahoo.com |
| Israel | |
| Ben-Gurion University of the Negev, Sial Research Center for Family Medicine and Primary Care | Recruiting |
| Beer-Sheva, Israel, 653 | |
| Contact: Pesach Shvartzman, MD 972-8-6477429 | |
| Principal Investigator: Valentina Semionov, MD | |
| Study Chair: | Pesach Shvartzman | Ben-Gurion University of the Negev |
More Information
| ClinicalTrials.gov Identifier: | NCT00320892 History of Changes |
| Other Study ID Numbers: | SOR416506CTIL |
| Study First Received: | May 1, 2006 |
| Last Updated: | January 21, 2009 |
| Health Authority: | Israel: Ministry of Health |
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Death Rattle Noise level Primary Care |
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Death Pathologic Processes Atropine Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Anti-Arrhythmia Agents Cardiovascular Agents Bronchodilator Agents Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Mydriatics Parasympatholytics Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |