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

NeuroTherapia, Inc. logo

NeuroTherapia, Inc.

Status

Withdrawn

Conditions

General Anesthesia
Nitrous Oxide
Abdominal Hysterectomy (& Wertheim)

Treatments

Drug: Nitrous oxide
Other: General anesthesia with oxygen

Study type

Interventional

Funder types

Other

Identifiers

NCT01622335
1491-952

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

0 participants in 2 patient groups, including a placebo group

General anesthesia with oxygen
Placebo Comparator group
Description:
General anesthesia and Air
Treatment:
Other: General anesthesia with oxygen
nitrous oxide and general anesthesia
Experimental group
Description:
General anesthesia with Nitrous Oxide
Treatment:
Drug: Nitrous oxide

Trial contacts and locations

1

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Central trial contact

Abdulkadir Atim, M.D.

Data sourced from clinicaltrials.gov

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