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

NCT ID: NCT01622335

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2023-12-31

Brief 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.

Detailed 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.

Conditions

Abdominal Hysterectomy (& Wertheim); Nitrous Oxide; General Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

General anesthesia with oxygen

General anesthesia and Air

Group Type: PLACEBO_COMPARATOR

General anesthesia with oxygen

Intervention Type: OTHER

General anesthesia with(Air, 70%, O2 30%) 1-5 L, Sevoflurane 1-2%, ETCO2: 32-35 mmHg.

nitrous oxide and general anesthesia

General anesthesia with Nitrous Oxide

Group Type: EXPERIMENTAL

Nitrous oxide

Intervention Type: DRUG

General anesthesia with Nitrous Oxide, 70%, O2 30%) 1-5 L, Sevoflurane 1-2%, ETCO2: 32-35 mmHg.

Interventions

Nitrous oxide

General anesthesia with Nitrous Oxide, 70%, O2 30%) 1-5 L, Sevoflurane 1-2%, ETCO2: 32-35 mmHg.

Intervention Type: DRUG

General anesthesia with oxygen

General anesthesia with(Air, 70%, O2 30%) 1-5 L, Sevoflurane 1-2%, ETCO2: 32-35 mmHg.

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Alparslan Turan

Principal Investigatgor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alparslan Turan, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Gulhane Military Medical Academy Hospital

Etlik, Ankara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

1491-952

Identifier Type: -

Identifier Source: org_study_id