Colonoscopy ProcedurePhase 4KALINAGNCT00930358
Safety Study of Colonoscopy Under Sedation
A Phase 4 study testing MEOPA and general anaesthesia in people with Colonoscopy Procedure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of this study was to compare the analgesia provided by nitrous oxide/oxygen sedation or general anesthesia for colonoscopy Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colonoscopy Procedure
- What is being tested?
- MEOPA and general anaesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2009to Jan 2011
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient referred for colonoscopy with general anesthesia
- Age above 18 et below 75 year
- Patient who gave an informed consent
Who cannot join
- Age below 18 ou above 75
- Need for gastroscopy in the same procedure than colonoscopy
- History of surgery wih resection more extended than half of the colon
- Dementia with autonomy loss or psychiatric disorder non controlled by therapeutic
- Severe congestive heart failure or evolutive heart ischemia
- Recent cerebral stroke
Show all 11Show fewer
- Hemodynamic instability
- Respiratory failure, severe chronic obstructive pulmonary (including asthma) or progressive pneumothorax
- Hepatic failure (Child-Pugh score> 9)
- Terminal renal failure 11 Hematopoietic disorders
- 12. Pathology with expected survival shorter than the duration of the study and cancer excepted basal cell carcinoma of the skin 13. Alcohol consumption higher than 100 gr per day 14. Pregnancy or breastfeeding at the inclusion period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tolerance and Acceptability of Colonoscopy Under Sedation by an Equimolar Mixture of Oxygen and Nitrous Oxide. Comparison With General Anesthesia in a Randomized, Multicentric Study.
The aim of this study was to compare the analgesia provided by nitrous oxide/oxygen sedation or general anesthesia for colonoscopy
Read the detailed description
The purpose of this protocol is to compare two methods of analgesia/sedation for colonoscopy. Sedation and analgesia induced by a 50% nitrous oxide/oxygen mixture could sufficient to allow the practice of colonoscopy instead of general anesthesia which is accompanied with certain risks and post procedure drowsiness.
- Conditions
- Colonoscopy Procedure
- Being tested
- MEOPA, general anaesthesia
- Keywords
- Sedation, Colonoscopy, General anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEOPADrug
Also called anaesthetic gaz inhalation
anaesthetic gaz inhalation
general anaesthesiaDrug
Also called Anaesthetic intravenous route
Anaesthetic intravenous route
| Study group | Role | What they receive |
|---|---|---|
| MEOPA | Experimental | MEOPA : equimolar nitrous oxide/oxygen mixture Receives: Drug: MEOPA |
| General anesthesia | Active comparator | Gold standard Receives: Drug: general anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who have well tolerated the colonoscopy as assessed by visual analogic scale (>75/100)
Measured: Immediately after the colonoscopy
The mean grade of patient anxiety before endoscopy
The mean grade of patient anxiety before endoscopy
Measured: After the colonoscopy
Secondary outcomes (12)
The mean tolerability of the colonoscopy between the group with sedation by nitrous oxide/oxygen mixture and the group with anesthesia
Measured: after the colonoscopy
The mean pain intensity during the procedure on a visual analogic scale
Measured: after the colonoscopy
The mean patient satisfaction on a visual analogic scale.
Measured: after the colonoscopy
The percentage of patients who agree to repeat the procedure in similar circumstances.
Measured: after the colonoscopy
The grade of difficulty of the colonoscopy evaluated by the endoscopist
Measured: After the colonoscopy
The mean duration of the endoscopy
Measured: After the colonoscopy
The percentage of caecum intubation
Measured: After the colonoscopy
The percentage of ileal intubation
Measured: After the colonoscopy
The opinion of the endoscopist on the tolerance of the colonoscopy
Measured: After the colonoscopy
The time to hospital discharge
Measured: After the issue of the colonoscopy
The Aldrete's score at the hospital discharge
Measured: After the colonoscopy
The number of patient who have refused the inclusion
Measured: After the issue of the colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startFeb 2009
- Primary completionJan 2011
- Study completionJan 2011
Why it stopped: This study was stopped due to low inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colonoscopy ProcedureStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Dominique Lamarque, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930358
- Sponsor's protocol ID
- P060240
- Acronym
- KALINAG
- Status last verified
- Apr 2011
- First submitted
- 29 Jun 2009
- Last updated
- 6 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Trojan J, Saunders BP, Woloshynowych M, Debinsky HS, Williams CB. Immediate recovery of psychomotor function after patient-administered nitrous oxide/oxygen inhalation for colonoscopy. Endoscopy. 1997 Jan;29(1):17-22. doi: 10.1055/s-2007-1004055.
PubMed 9083731
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance and Acceptability of Colonoscopy Under Sedation by an Equimolar Mixture of Oxygen and Nitrous Oxide. Comparison With General Anesthesia in a Randomized, Multicentric Study.
- ClinicalTrials.gov ID
- NCT00930358
- Acronym / sponsor ID
- KALINAG / P060240
- Conditions
- Colonoscopy Procedure
- Keywords
- Sedation, Colonoscopy, General anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was stopped due to low inclusion
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 30 Jun 2009 (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 aim of this study was to compare the analgesia provided by nitrous oxide/oxygen sedation or general anesthesia for colonoscopy
Detailed description
The purpose of this protocol is to compare two methods of analgesia/sedation for colonoscopy. Sedation and analgesia induced by a 50% nitrous oxide/oxygen mixture could sufficient to allow the practice of colonoscopy instead of general anesthesia which is accompanied with certain risks and post procedure drowsiness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MEOPA | Experimental | Drug: MEOPAMEOPA : equimolar nitrous oxide/oxygen mixture |
| General anesthesia | Active comparator | Drug: general anaesthesiaGold standard |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient referred for colonoscopy with general anesthesia
- Age above 18 et below 75 year
- Patient who gave an informed consent
Key exclusion criteria (11 listed)
- Age below 18 ou above 75
- Need for gastroscopy in the same procedure than colonoscopy
- History of surgery wih resection more extended than half of the colon
- Dementia with autonomy loss or psychiatric disorder non controlled by therapeutic
- Severe congestive heart failure or evolutive heart ischemia
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 |
|---|---|---|
| MEOPAAlso: anaesthetic gaz inhalationanaesthetic gaz inhalation | Drug | MEOPA |
| general anaesthesiaAlso: Anaesthetic intravenous routeAnaesthetic intravenous route | Drug | General anesthesia |
Primary outcome
Percentage of patients who have well tolerated the colonoscopy as assessed by visual analogic scale (>75/100)
Time frame: Immediately after the colonoscopy
The mean grade of patient anxiety before endoscopy
Time frame: After the colonoscopy
The mean grade of patient anxiety before endoscopy
12 secondary outcomes
The mean tolerability of the colonoscopy between the group with sedation by nitrous oxide/oxygen mixture and the group with anesthesia
Time frame: after the colonoscopy
The mean pain intensity during the procedure on a visual analogic scale
Time frame: after the colonoscopy
The mean patient satisfaction on a visual analogic scale.
Time frame: after the colonoscopy
The percentage of patients who agree to repeat the procedure in similar circumstances.
Time frame: after the colonoscopy
The grade of difficulty of the colonoscopy evaluated by the endoscopist
Time frame: After the colonoscopy
The mean duration of the endoscopy
Time frame: After the colonoscopy
The percentage of caecum intubation
Time frame: After the colonoscopy
The percentage of ileal intubation
Time frame: After the colonoscopy
The opinion of the endoscopist on the tolerance of the colonoscopy
Time frame: After the colonoscopy
The time to hospital discharge
Time frame: After the issue of the colonoscopy
The Aldrete's score at the hospital discharge
Time frame: After the colonoscopy
The number of patient who have refused the inclusion
Time frame: After the issue of the colonoscopy
Results and safety
The study was stopped early (reason given: This study was stopped due to low inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2011.
- Background: PubMed 9083731Trojan J, Saunders BP, Woloshynowych M, Debinsky HS, Williams CB. Immediate recovery of psychomotor function after patient-administered nitrous oxide/oxygen inhalation for colonoscopy. Endoscopy. 1997 Jan;29(1):17-22. doi: 10.1055/s-2007-1004055.
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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.
Dominique Lamarque, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MEOPA and general anaesthesia in people with Colonoscopy Procedure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 inclusion and 11 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: stopped early, as of the sponsor's last update on 6 Apr 2011. 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 France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: This study was stopped due to low inclusion). Results are not available in the source record.
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?
Percentage of patients who have well tolerated the colonoscopy as assessed by visual analogic scale (>75/100) (time frame: Immediately after the colonoscopy). 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?
On the ClinicalTrials.gov record for NCT00930358, which also lists 1 linked publication.
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 6 Apr 2011; AzTrials last refreshed its copy on 1 Nov 2026.