Unique ID issued by UMIN | UMIN000040880 |
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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 |
Effect of Dexmedetomidine versus Remifentanil on early recovery from anesthesia and Morphine consumption in laparoscopic sleeve gastrectomy obese patients
Effect of Dexmedetomidine versus Remifentanil on early recovery and Morphine consumption in laparoscopic sleeve gastrectomy patients
Impact of intraoperative use of Dexmedetomidine versus Remifentanil on postoperative enhanced recovery and Morphine consumption in obese patients for laparoscopic sleeve gastrectomy
Impact of intraoperative use of dexmedetomidine versus remifentanil on the enhanced recovery characteristics following laparoscopic sleeve gastrectomy. A clinical observational pilot study
Asia(except Japan) |
No any
Anesthesiology |
Others
NO
To evaluate the impact of intraoperative anesthesia adjuvants Dexmedetomidine and Remifentanil on postoperative pain in obese patients scheduled for laparoscopic sleeve gastrectomy
Others
To evaluate the impact of Dexmedetomidine and Remifentanil on Morphine consumption and quality of recovery in obese patients scheduled for laparoscopic sleeve gastrectomy.
Exploratory
Pragmatic
Not applicable
To assess the effect of Dexmedetomidine and Remifentanil on postoperative pain in obese patients scheduled for laparoscopic sleeve gastrectomy under general anesthesia
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.
Interventional
Parallel
Randomized
Cluster
Double blind -all involved are blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Prevention
Medicine |
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.
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.
18 | years-old | <= |
60 | years-old | >= |
Male and Female
1- ASA I, II
2- Age 18-60 years
3- Either gender
4- Obese patients (BMI >35 for laparoscopic
sleeve gastrectomy)
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
40
1st name | Abdul Sattar |
Middle name | |
Last name | Narejo |
King Saud University Medical City
Anesthesia
P.O. Box 7805 Riyadh, 11472 K.S.A.
Department of Anesthesia, King Saud University Medical City, Riyadh, Saudi Arabia
00966556314525
narejo27@hotmail.com
1st name | Abdul Sattar |
Middle name | |
Last name | Narejo |
King Saud University Medical City
Anesthesia
P.O. Box 7805 Riyadh, 11472 K.S.A.
Department of Anesthesia, King Saud University Medical City, Riyadh, Saudi Arabia
00966556314525
https://medicalcity.ksu.edu.sa/en
narejo27@hotmail.com
King Saud University College of Medicine
Riyadh, Saudi Arabia
INSTITUTIONAL REVIEW BOARD (201)
Saudi Anesthesia Society (SAS)
Riyadh, Saudi Arabia
http://www.saudianas.com/contact
Non profit foundation
Kingdom of Saudi Arabia
King Saud University College of Medicine and King Khalid University Hospital
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.
(+966-11) 469-1531; (+966-11) 469-1532
rdeocampo@ksu.edu.sa
NO
King Saud University College of Medicine and King Khalid University Hospital (Riyadh)
2020 | Year | 06 | Month | 24 | Day |
Unpublished
40
Delay expected |
COVID-19 Pandemic
-Dexmedetomidine
-Remifentanil
-Laparoscopic Sleeve Gastrectomy
-Pain
-Enhanced Recovery after Surgery & Anesthesia
-Morphine Consumption
-Mild Hypotension
-Bradycardia
-Postoperative Nausea & Vomiting (PONV)
-Sedation
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)
Completed
2019 | Year | 11 | Month | 10 | Day |
2019 | Year | 12 | Month | 24 | Day |
2019 | Year | 12 | Month | 25 | Day |
2020 | Year | 03 | Month | 26 | Day |
2020 | Year | 05 | Month | 14 | Day |
2020 | Year | 05 | Month | 14 | Day |
2020 | Year | 06 | Month | 24 | Day |
2020 | Year | 09 | Month | 20 | Day |
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 |
Value
https://center6.umin.ac.jp/ice/46626