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Ketamine Infusion vs Dexmedetomidine Infusion in Obese Patients Undergoing Bariatric Surgery

Primary Purpose

Morbid Obesity, Surgery

Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Ketamine
Dexmedetomidine
Normal Saline 0.9%
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ainshams University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Ketamine

Dexmedetomidine

Normal Saline 0.9%

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

compare the use of ketamine versus dexmedetomidine when used as perioperative infusion in obese patients undergoing laparoscopic bariatric surgery regarding their analgesic efficacy
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.

Secondary Outcome Measures

any side effects or drawbacks (PONV and effects on consciousness) that might associate with their use
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.

Full Information

First Posted
September 26, 2020
Last Updated
July 27, 2021
Sponsor
Ain Shams University
Collaborators
Ministry of Health, Kuwait
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1. Study Identification

Unique Protocol Identification Number
NCT04576975
Brief Title
Ketamine Infusion vs Dexmedetomidine Infusion in Obese Patients Undergoing Bariatric Surgery
Official Title
Perioperative Use of Ketamine Infusion vs Dexmedetomidine Infusion as Analgesic in Obese Patients Undergoing Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 20, 2021 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
Collaborators
Ministry of Health, Kuwait

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketamine
Arm Type
Experimental
Arm Description
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
Arm Title
Dexmedetomidine
Arm Type
Experimental
Arm Description
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
Arm Title
Normal Saline 0.9%
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Normal Saline 0.9%
Intervention Description
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.
Primary Outcome Measure Information:
Title
compare the use of ketamine versus dexmedetomidine when used as perioperative infusion in obese patients undergoing laparoscopic bariatric surgery regarding their analgesic efficacy
Description
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.
Time Frame
one year throughout the study
Secondary Outcome Measure Information:
Title
any side effects or drawbacks (PONV and effects on consciousness) that might associate with their use
Description
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.
Time Frame
one year throughout the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bahaa El-Din E Ali, PhD
Organizational Affiliation
Ainshams University, Egypt
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmed N El-Shaer, PhD
Organizational Affiliation
Ainshams University, Egypt
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohammad A Khaja, FCARCSI
Organizational Affiliation
Ministry of Health, Kuwait
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohammed O Taeimah, PhD
Organizational Affiliation
Ainshams University, Egypt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maha S Al Derh, PhD
Organizational Affiliation
Ainshams University, Egypt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Belal N Khalil, M.Sc
Organizational Affiliation
Ainshams University, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ainshams University Hospitals
City
Cairo
ZIP/Postal Code
00202
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
29904577
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
21148651
Citation
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Results Reference
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PubMed Identifier
26001751
Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Ketamine Infusion vs Dexmedetomidine Infusion in Obese Patients Undergoing Bariatric Surgery

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