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NCT01622335 Clinical Trial

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

General Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01622335
Other study ID # 1491-952
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 2012
Est. completion date December 2023

Study information
Verified date July 2023
Source The Cleveland Clinic
Contact Abdulkadir Atim, M.D.
Phone +90 312 304 5911
Email drkadiratim@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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. In the first group of patients will receive Nitrous Oxide and In the second group of patients will receive oxygen during the general anesthesia.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 2023
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility 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).

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Nitrous oxide
General anesthesia with Nitrous Oxide, 70%, O2 30%) 1-5 L, Sevoflurane 1-2%, ETCO2: 32-35 mmHg.
Other:
• General anesthesia with oxygen
General anesthesia with(Air, 70%, O2 30%) 1-5 L, Sevoflurane 1-2%, ETCO2: 32-35 mmHg.

Locations
Country Name City State
Turkey Gulhane Military Medical Academy Hospital Etlik Ankara

Sponsors (1)
Lead Sponsor Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Nitrous oxide and chronic pain The of the effect of 50% N20/50% O2 on post hysterectomy in prevention of chronic pain. 30 days post operative
Primary Nitrous oxide and opioid consumption The effect of 50% N20/50% O2 on post hysterectomy in decrease of opioid consumption. 4 hours post operative
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