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Clinical trial

Effect OF Nitrous Oxide On Acute Pain and Opioid Consumption, and Chronic

ID
Name
1491-952
Description
The study is prospective and double blind. In the clinic, patients undergoing hysterectomy that meet the criteria for inclusion into the study and agreed to participate in the study will be randomized into two groups.
Trial arms
Trial start
2012-05-01
Estimated PCD
2022-12-01
Trial end
2023-12-01
Status
Withdrawn
Treatment
Nitrous oxide
General anesthesia with Nitrous Oxide, 70%, O2 30%) 1-5 L, Sevoflurane 1-2%, ETCO2: 32-35 mmHg.
Arms:
nitrous oxide and general anesthesia
General anesthesia with oxygen
General anesthesia with(Air, 70%, O2 30%) 1-5 L, Sevoflurane 1-2%, ETCO2: 32-35 mmHg.
Arms:
General anesthesia with oxygen
Primary endpoint
Nitrous oxide and chronic pain
30 days post operative
Nitrous oxide and opioid consumption
4 hours post operative
Eligibility criteria
Inclusion Criteria: * 18 to 65 years old at time of the first procedure * Female * American Society of Anesthesiologists physical status I or II * Hysterectomy undergoing the general anesthesia Exclusion Criteria: * Neuropathic disease * Chronic opioid users * Contraindication for Nitrous Oxide receive * Consent will not be obtained patient * Psychiatric disorders * Current or recent drug abuse (within past 6 months).
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}
Updated at
2024-05-07

1 organization

1 product

3 indications

Organization
The Cleveland Clinic
Product
Nitrous oxide
Indication
Abdominal Hysterectomy
Indication
Nitrous Oxide
Indication
General Anesthesia