Abdominal Hysterectomy (& Wertheim)NCT01622335
Effect OF Nitrous Oxide On Acute Pain and Opioid Consumption, and Chronic Pain After Hysterectomy
A study testing Nitrous oxide and General anesthesia with oxygen in people with Abdominal Hysterectomy (& Wertheim) and Nitrous Oxide, run by The Cleveland Clinic at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Abdominal Hysterectomy (& Wertheim), Nitrous Oxide, General Anesthesia
- What is being tested?
- Nitrous oxide and General anesthesia with oxygen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2012to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane Military Medical Academy Hospital
Etlik, Ankara, 06018
About this study
Official title: Effect OF Nitrous Oxide On Acute Pain and Opioid Consumption, and Chronic
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.
Read the 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.
- Being tested
- Nitrous oxide, General anesthesia with oxygen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrous oxideDrug
General anesthesia with Nitrous Oxide, 70%, O2 30%) 1-5 L, Sevoflurane 1-2%, ETCO2: 32-35 mmHg.
General anesthesia with oxygenOther
General anesthesia with(Air, 70%, O2 30%) 1-5 L, Sevoflurane 1-2%, ETCO2: 32-35 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia with oxygen | Placebo comparator | General anesthesia and Air Receives: Other: General anesthesia with oxygen |
| nitrous oxide and general anesthesia | Experimental | General anesthesia with Nitrous Oxide Receives: Drug: Nitrous oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nitrous oxide and chronic pain
The of the effect of 50% N20/50% O2 on post hysterectomy in prevention of chronic pain.
Measured: 30 days post operative
Nitrous oxide and opioid consumption
The effect of 50% N20/50% O2 on post hysterectomy in decrease of opioid consumption.
Measured: 4 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startMay 2012 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Study was terminated per Principal Investigator decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Hysterectomy (& Wertheim)Studies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alparslan Turan, The Cleveland Clinic
- Investigators
- Alparslan Turan, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622335
- Sponsor's protocol ID
- 1491-952
- Status last verified
- May 2024
- First submitted
- 15 Jun 2012
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect OF Nitrous Oxide On Acute Pain and Opioid Consumption, and Chronic
- ClinicalTrials.gov ID
- NCT01622335
- Acronym / sponsor ID
- 1491-952
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was terminated per Principal Investigator decision.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- May 2012 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 19 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General anesthesia with oxygen | Placebo comparator | Other: General anesthesia with oxygenGeneral anesthesia and Air |
| nitrous oxide and general anesthesia | Experimental | Drug: Nitrous oxideGeneral anesthesia with Nitrous Oxide |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Neuropathic disease
- Chronic opioid users
- Contraindication for Nitrous Oxide receive
- Consent will not be obtained patient
- Psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitrous oxideGeneral anesthesia with Nitrous Oxide, 70%, O2 30%) 1-5 L, Sevoflurane 1-2%, ETCO2: 32-35 mmHg. | Drug | nitrous oxide and general anesthesia |
| General anesthesia with oxygenGeneral anesthesia with(Air, 70%, O2 30%) 1-5 L, Sevoflurane 1-2%, ETCO2: 32-35 mmHg. | Other | General anesthesia with oxygen |
Primary outcome
Nitrous oxide and chronic pain
Time frame: 30 days post operative
The of the effect of 50% N20/50% O2 on post hysterectomy in prevention of chronic pain.
Nitrous oxide and opioid consumption
Time frame: 4 hours post operative
The effect of 50% N20/50% O2 on post hysterectomy in decrease of opioid consumption.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alparslan Turan, M.D. principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nitrous oxide and General anesthesia with oxygen in people with Abdominal Hysterectomy (& Wertheim) and Nitrous Oxide, run by The Cleveland Clinic at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nitrous oxide and chronic pain (time frame: 30 days post operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.