Overview

This trial is active, not recruiting.

Conditions abdominal hysterectomy (& wertheim), nitrous oxide, general anesthesia
Treatments nitrous oxide, general anesthesia with oxygen
Sponsor The Cleveland Clinic
Start date May 2012
End date December 2016
Trial size 200 participants
Trial identifier NCT01622335, 1491-952

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose supportive care
Arm
(Placebo Comparator)
General anesthesia and Air
general anesthesia with oxygen
General anesthesia with(Air, 70%, O2 30%) 1-5 L, Sevoflurane 1-2%, ETCO2: 32-35 mmHg.
(Experimental)
General anesthesia with Nitrous Oxide
nitrous oxide
General anesthesia with Nitrous Oxide, 70%, O2 30%) 1-5 L, Sevoflurane 1-2%, ETCO2: 32-35 mmHg.

Primary Outcomes

Measure
Nitrous oxide and chronic pain
time frame: 30 days post operative
Nitrous oxide and opiod consumption
time frame: 4 hours post operative

Eligibility Criteria

Female participants from 18 years up to 65 years old.

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 opiod users - Contraindication for Nitrous Oxide receive - Consent will not be obtained patient - Psychiatric disorders - Current or recent drug abuse (within past 6 months).

Additional Information

Official title Effect OF Nitrous Oxide On Acute Pain and Opioid Consumption, and Chronic
Principal investigator Alparslan Turan, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by The Cleveland Clinic.