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Ketamine Infusion vs Dexmedetomidine Infusion in Obese Patients Undergoing Bariatric Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04576975
Recruitment Status : Active, not recruiting
First Posted : October 6, 2020
Last Update Posted : July 28, 2021
Sponsor:
Collaborator:
Ministry of Health, Kuwait
Information provided by (Responsible Party):
Belal Nabil Mahfouz Khalil, Ain Shams University

Tracking Information
First Submitted Date  ICMJE September 26, 2020
First Posted Date  ICMJE October 6, 2020
Last Update Posted Date July 28, 2021
Actual Study Start Date  ICMJE April 20, 2021
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2020)
compare the use of ketamine versus dexmedetomidine when used as perioperative infusion in obese patients undergoing laparoscopic bariatric surgery regarding their analgesic efficacy [ Time Frame: one year throughout the study ]
They will be assessed for sedation score with Modified Observer's assessment of alertness/sedation scale [MOAS/S] . The score will be repeated at 10, 30 and 60 minutes. Agitated 6 Responds readily to name spoken in normal tone (alert) 5 Lethargic response to name spoken in normal tone 4 Responds only after name is called loudly and/or repeatedly 3 Responds only after mild prodding or shaking 2 Does not respond to mild prodding or shaking 1 Does not respond to deep stimulus 0 The patient will be assessed for pain by using the Numerical Rating Scale [NRS] with score is 0 for no pain and 10 for excruciating pain. The NRS score will be recorded 30 and 60 mins and 2, 6, 12, and 24 h after the surgery. All patients will receive paracetamol (Perfilgan ®) 1 gm IV every 6 hours for 24 hours postoperatively. A rescue dose of morphine 4 mg per needed with minimum 6 hours interval between doses if the NRS Score is ≥ 4. total doses of morphine will be calculated.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2020)
any side effects or drawbacks (PONV and effects on consciousness) that might associate with their use [ Time Frame: one year throughout the study ]
All Patients will be assessed for PONV by using PONV Intensity Scale . The score will be done 6 hours and 24 hours after the surgery. Ondansetron (Zofran®) 4 mg will be given if the patient developed intense sensation of nausea and to be repeated after 30 Minutes All the vital data will be recorded at 10 minutes, 30 minutes, 1 hour, 2 hours, 6 hours, 12 hours and 24 hours from discharge of operating room. Postoperative complication (such as; airway obstruction, development of hypoxia, serious nausea and vomiting …, etc.) will be recorded.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine Infusion vs Dexmedetomidine Infusion in Obese Patients Undergoing Bariatric Surgery
Official Title  ICMJE Perioperative Use of Ketamine Infusion vs Dexmedetomidine Infusion as Analgesic in Obese Patients Undergoing Bariatric Surgery
Brief Summary

The surgeries that involve treatment of morbid obesity, i.e. bypass procedure and sleeve gastrectomy, are collectively covered under the term 'bariatric surgery'. The frequency of bariatric surgery has been increasing worldwide for patients with medically complicated obesity who have difficulty losing weight by other methods

The growth of bariatric surgery is accompanied with development of anesthetic techniques to maintain patient safety and improve outcome. Treatment with narcotics in obese patients has dual effect. Increased use of narcotics are associated with multiple complications including Postoperative Nausea and Vomiting (PONV) , respiratory depression and elevated risk of Obstructive Sleep Apnea (OSA) complications . On the other hand, the reduction in opioid use may result in acute post-operative pain that may limit post-surgery rehabilitation. Therefore, we need to minimize opioid use and employ some other drugs which, besides having analgesia, has an opioid-sparing effect also.

Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has analgesic properties in sub-anesthetic doses. When used in low dose (0.3 to 0.5 mg/kg) by ideal body weight, it is an analgesic, anti-hyperalgesic, and prevents development of opioid tolerance.

Dexmedetomidine is selective α2-Adrenoceptor agonist that has been used as an adjuvant to anesthetic agents in perioperative period for several adventitious profile as well as tolerated side effects . While dexmedetomidine is emerging as a beneficial adjunct to the analgesic regimen in the perioperative period, its utilization is not routinely widespread .

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Blinding of patients and assigning them randomly to their groups will be done by giving patients serial numbers, using a computer program (Microsoft Excel 365). Investigators will be blinded to group assignments and drug coding.
Primary Purpose: Treatment
Condition  ICMJE
  • Morbid Obesity
  • Surgery
Intervention  ICMJE
  • Drug: Ketamine
    compare the use of ketamine versus dexmedetomidine when used as perioperative infusion in obese patients undergoing laparoscopic bariatric surgery regarding their analgesic efficacy as well as any side effects or drawbacks (PONV and effects on consciousness) that might associate with their use.
  • Drug: Dexmedetomidine
    compare the use of ketamine versus dexmedetomidine when used as perioperative infusion in obese patients undergoing laparoscopic bariatric surgery regarding their analgesic efficacy as well as any side effects or drawbacks (PONV and effects on consciousness) that might associate with their use.
  • Drug: Normal Saline 0.9%
    compare the use of ketamine versus dexmedetomidine when used as perioperative infusion in obese patients undergoing laparoscopic bariatric surgery regarding their analgesic efficacy as well as any side effects or drawbacks (PONV and effects on consciousness) that might associate with their use.
Study Arms  ICMJE
  • Experimental: Ketamine
    This group will receive a bolus dose of Ketamine [Ketamine HCL - Sterop, Belgium] (0.3 mg/kg) by the ideal body weight diluted with 0.9% Normal Saline over 10 minutes by 20 ml syringe infused before induction. After which Ketamine infusion (500 mg vial diluted over 50 cc infusion syringe, concentration 10 mg/ml) will start with rate of 0.3 mg/kg/hr till 10 Minutes before the end of the surgery
    Intervention: Drug: Ketamine
  • Experimental: Dexmedetomidine
    This group will receive a bolus dose of Dexmedetomidine [Precedex® -Hospira, USA] (0.5 µcg/kg) by the ideal body weight diluted with 0.9% Normal Saline over 10 minutes by 20 ml syringe infused before induction. After which, the Dexmedetomidine infusion (200 µcg vial diluted over 50 cc infusion syringe, concentration 4 µcg/ml) will start with rate of 0.5 µcg/kg/hr till 10 Minutes before the end of the surgery
    Intervention: Drug: Dexmedetomidine
  • Placebo Comparator: Normal Saline 0.9%
    This group will receive a bolus dose of NS 0.9% over 10 minutes by 20 ml syringe infused before induction. After which, NS 0.9% (50 ml over 50 cc syringe) will be infused.
    Intervention: Drug: Normal Saline 0.9%
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 27, 2021)
90
Original Estimated Enrollment  ICMJE
 (submitted: September 30, 2020)
30
Estimated Study Completion Date  ICMJE July 1, 2022
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • BMI > 35 kg/m2
  • ASA physical status II & III (according to BMI)
  • Undergoing laparoscopic bariatric surgery

Exclusion Criteria:

  • Patients refusal
  • ASA physical status: IV (according to BMI)
  • History of hypersensitivity to dexmedetomidine and/or ketamine
  • History of substance abuse (Benzodiazepines) or Chronic opioid use
  • Psychiatric or Seizure disorder
  • uncontrolled hypertension or heart block
  • uncontrolled diabetes
  • Surgical Complication
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04576975
Other Study ID Numbers  ICMJE FMASU M D 108 / 2020
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Belal Nabil Mahfouz Khalil, Ain Shams University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Ain Shams University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Ministry of Health, Kuwait
Investigators  ICMJE
Study Director: Bahaa El-Din E Ali, PhD Ainshams University, Egypt
Study Director: Ahmed N El-Shaer, PhD Ainshams University, Egypt
Study Director: Mohammad A Khaja, FCARCSI Ministry of Health, Kuwait
Principal Investigator: Mohammed O Taeimah, PhD Ainshams University, Egypt
Principal Investigator: Maha S Al Derh, PhD Ainshams University, Egypt
Principal Investigator: Belal N Khalil, M.Sc Ainshams University, Egypt
PRS Account Ain Shams University
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP