UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009161 |
|---|---|
| Receipt number | R000010745 |
| Scientific Title | Comparative study of the effects of different intra-operative end-tidal CO2 levels on intra and post-operative anesthesia complication in adult patients under general anesthesia for PCNL. |
| Date of disclosure of the study information | 2012/10/24 |
| Last modified on | 2014/03/19 16:25:03 |
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Basic information
Public title
Comparative study of the effects of different intra-operative end-tidal CO2 levels on intra and post-operative anesthesia complication in adult patients under general anesthesia for PCNL.
Acronym
Effects of CO2 levels on anesthesia complication
Scientific Title
Comparative study of the effects of different intra-operative end-tidal CO2 levels on intra and post-operative anesthesia complication in adult patients under general anesthesia for PCNL.
Scientific Title:Acronym
Effects of CO2 levels on anesthesia complication
Region
| Asia(except Japan) |
Condition
Condition
A descriptive study has shown relative safety and benefits of higher CO2 levels and mild hypercapnia. Effects of different levels of end-tidal CO2 concentration have not been evaluated in a controlled trial.
Classification by specialty
| Pneumology | Surgery in general | Anesthesiology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparing proportions of different intra-operative and post-operative anesthesia complications among three groups of subjects with different levels of end-tidal CO2
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rates of cardio-respiratory complications
Key secondary outcomes
Mean time to full recovery
Mean recovery room stay duration
Postoperative rates of shiverng, restlessness, nausea and vomiting
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Mild hypocapnia
Interventions/Control_2
Normocapnia
Interventions/Control_3
Mild hypercapnia
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient consent
Adult
Surgery PCNL
Key exclusion criteria
Addiction
Smoker
History of cardiorespiratory
Elevated BUN or creatinine
BMI > 30
History of PONV
Recent anesthesia with volatiles
Target sample size
78
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mahmoud Saghaei |
Organization
Isfahan University of Medical Sciences
Division name
Department of Anesthesia
Zip code
Address
Al-Zahra Medical Center
TEL
+983116249031
mahmood.saghaei@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mahmoud Saghaei |
Organization
Isfahan University of Medical Sciences
Division name
Department of Anesthesia
Zip code
Address
Al-Zahra Medical Center
TEL
+983116249031
Homepage URL
http://www.saghaei.net
mahmood.saghaei@gmail.com
Sponsor or person
Institute
Department of Anesthesia, Isfahan University of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Research Department, Isfahan University of Medical Sciences
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Iran
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Al-Zahra Medical Center, Al-Zahra hospital, Anesthesia Section
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://scholar.google.com/citations?view_op=view_citation&hl=en&user=iCabiLYAAAAJ&pagesize=100&citation_for_view=iCabiLYAAAAJ:e5wmG9Sq2KIC
Number of participants that the trial has enrolled
Results
Results: Seventy-five patients completed the study (52 male and 23 female). Ten (38.5%), four (16%) and two (8.3%) patients developed post-operative vomiting in the hypocapnia, normocapnia and hypercapnia groups, respectively (P = 0.025). The nausea score was significantly lower in the hypercapnic group compared with the other groups (3.9 +- 1.8, 3.2 +- 2.1 and 1.3 +1 1.8 in the hypocapnia, normocapnia and hypercapnia groups, respectively; P = 0.000). Time to return of spontaneous respiration and awakening were significantly decreased in the hypercapnia group compared with the other groups (P < 0.01).
Conclusion: Mild intra-operative hypercapnia has a protecting effect against the development of post-operative nausea and vomiting and decreases the duration of emergence and recovery from general anesthesia.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 09 | Month | 15 | Day |
Date of closure to data entry
| 2012 | Year | 09 | Month | 15 | Day |
Date trial data considered complete
| 2012 | Year | 09 | Month | 15 | Day |
Date analysis concluded
| 2012 | Year | 10 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 22 | Day |
Last modified on
| 2014 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010745
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
