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

NCT01622335 | Withdrawn

• 1 other identifier: 1491-952
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• Nitrous oxide and opioid consumption

  The effect of 50% N20/50% O2 on post hysterectomy in decrease of opioid consumption.

  4 hours post operative

Study Arms (2)

General anesthesia with oxygen

PLACEBO COMPARATOR

General anesthesia and Air

Other: General anesthesia with oxygen

nitrous oxide and general anesthesia

EXPERIMENTAL

General anesthesia with Nitrous Oxide

Drug: Nitrous oxide

Interventions

Nitrous oxide DRUG

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

nitrous oxide and general anesthesia

General anesthesia with oxygen OTHER

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

General anesthesia with oxygen

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Gulhane Military Medical Academy Hospital

Etlik, Ankara, 06018, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Nitrous Oxide; Anesthesia, General; Oxygen

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds; Anesthesia; Anesthesia and Analgesia; Chalcogens; Elements

Study Officials

• Alparslan Turan, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigatgor

Study Record Dates

• First Submitted: June 15, 2012
• First Posted: June 19, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

TU (1)