UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040880 |
|---|---|
| Receipt number | R000046626 |
| Scientific Title | Impact of intraoperative use of Dexmedetomidine versus Remifentanil on postoperative enhanced recovery and Morphine consumption in obese patients for laparoscopic sleeve gastrectomy |
| Date of disclosure of the study information | 2020/06/24 |
| Last modified on | 2020/09/20 02:29:04 |
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Basic information
Public title
Effect of Dexmedetomidine versus Remifentanil on early recovery from anesthesia and Morphine consumption in laparoscopic sleeve gastrectomy obese patients
Acronym
Effect of Dexmedetomidine versus Remifentanil on early recovery and Morphine consumption in laparoscopic sleeve gastrectomy patients
Scientific Title
Impact of intraoperative use of Dexmedetomidine versus Remifentanil on postoperative enhanced recovery and Morphine consumption in obese patients for laparoscopic sleeve gastrectomy
Scientific Title:Acronym
Impact of intraoperative use of dexmedetomidine versus remifentanil on the enhanced recovery characteristics following laparoscopic sleeve gastrectomy. A clinical observational pilot study
Region
| Asia(except Japan) |
Condition
Condition
No any
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the impact of intraoperative anesthesia adjuvants Dexmedetomidine and Remifentanil on postoperative pain in obese patients scheduled for laparoscopic sleeve gastrectomy
Basic objectives2
Others
Basic objectives -Others
To evaluate the impact of Dexmedetomidine and Remifentanil on Morphine consumption and quality of recovery in obese patients scheduled for laparoscopic sleeve gastrectomy.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To assess the effect of Dexmedetomidine and Remifentanil on postoperative pain in obese patients scheduled for laparoscopic sleeve gastrectomy under general anesthesia
Key secondary outcomes
To assess the effect of Dexmedetomidine and Remifentanil on postoperative quality of recovery from general anesthesia (i.e. pain, hemodynamics, sedation, agitation, shivering, postoperative nausea & vomiting, length of hospital stay) and Morphine consumption in obese patients scheduled for laparoscopic sleeve gastrectomy.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Dexmedetomidine 200 micrograms (mics) diluted in 50 milliliters (ml) normal saline. The final concentration will be 4 mics/ml.
Dose 0.2- 0.7 mics/kg/hour under general anesthesia for the duration of surgery approximately 45 to 120 minutes.
Interventions/Control_2
Remifentanil 5 milligrams (mg) will also be diluted in 50 ml normal saline. The final concentration will be 100 mics/ml. Dose- 0.05-1 mics/kg/minute for the duration of surgery approximately 45 to 120 minutes.
Interventions/Control_3
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1- ASA I, II
2- Age 18-60 years
3- Either gender
4- Obese patients (BMI >35 for laparoscopic
sleeve gastrectomy)
Key exclusion criteria
1- Uncontrolled Hypertension
2- Age below 18 and older than 60
3- Non-Obese patients (BMI< 35)
4- Heart block > Ist degree
5- Allergic to morphine, alpha-2 agonist
5- Clinically significant neurological, cardiovascular, renal hepatic disease
6- History of drug abuse or chronic opioid use
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Abdul Sattar |
| Middle name | |
| Last name | Narejo |
Organization
King Saud University Medical City
Division name
Anesthesia
Zip code
P.O. Box 7805 Riyadh, 11472 K.S.A.
Address
Department of Anesthesia, King Saud University Medical City, Riyadh, Saudi Arabia
TEL
00966556314525
narejo27@hotmail.com
Public contact
Name of contact person
| 1st name | Abdul Sattar |
| Middle name | |
| Last name | Narejo |
Organization
King Saud University Medical City
Division name
Anesthesia
Zip code
P.O. Box 7805 Riyadh, 11472 K.S.A.
Address
Department of Anesthesia, King Saud University Medical City, Riyadh, Saudi Arabia
TEL
00966556314525
Homepage URL
https://medicalcity.ksu.edu.sa/en
narejo27@hotmail.com
Sponsor or person
Institute
King Saud University College of Medicine
Riyadh, Saudi Arabia
INSTITUTIONAL REVIEW BOARD (201)
Institute
Department
Personal name
Funding Source
Organization
Saudi Anesthesia Society (SAS)
Riyadh, Saudi Arabia
http://www.saudianas.com/contact
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Kingdom of Saudi Arabia
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
King Saud University College of Medicine and King Khalid University Hospital
Address
INSTITUTIONAL REVIEW BOARD (201) 3rd Floor Room 317, Block 22 (near Theatre C) King Saud University College of Medicine and King Khalid University Hospital P.O. Box 7805 Riyadh, 11472 K.S.A.
Tel
(+966-11) 469-1531; (+966-11) 469-1532
rdeocampo@ksu.edu.sa
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
King Saud University College of Medicine and King Khalid University Hospital (Riyadh)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
40
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
COVID-19 Pandemic
Date of the first journal publication of results
Baseline Characteristics
-Dexmedetomidine
-Remifentanil
-Laparoscopic Sleeve Gastrectomy
-Pain
-Enhanced Recovery after Surgery & Anesthesia
-Morphine Consumption
Participant flow
Adverse events
-Mild Hypotension
-Bradycardia
-Postoperative Nausea & Vomiting (PONV)
-Sedation
Outcome measures
Primary- Pain with 10 cm long Numerical Rating Scale (NRS)
Secondary- Enhance recovery from surgery & anesthesia in terms of (Hemodynamics, PONV, Shivering, sedation, agitation, length of hospital stay)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 26 | Day |
Date of closure to data entry
| 2020 | Year | 05 | Month | 14 | Day |
Date trial data considered complete
| 2020 | Year | 05 | Month | 14 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 24 | Day |
Last modified on
| 2020 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046626
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/09/20 | METHODOLOGY pdf.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2020/06/29 | Individual data specification.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/09/20 | Dex & Remi-coded.xlsx |
