Ketamine Infusion vs Dexmedetomidine Infusion in Obese Patients Undergoing Bariatric Surgery
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| ClinicalTrials.gov Identifier: NCT04576975 |
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Recruitment Status :
Active, not recruiting
First Posted : October 6, 2020
Last Update Posted : July 28, 2021
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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 .
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Morbid Obesity Surgery | Drug: Ketamine Drug: Dexmedetomidine Drug: Normal Saline 0.9% | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 90 participants |
| 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 |
| Official Title: | Perioperative Use of Ketamine Infusion vs Dexmedetomidine Infusion as Analgesic in Obese Patients Undergoing Bariatric Surgery |
| Actual Study Start Date : | April 20, 2021 |
| Estimated Primary Completion Date : | December 30, 2021 |
| Estimated Study Completion Date : | July 1, 2022 |
| Arm | Intervention/treatment |
|---|---|
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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
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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. |
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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
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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. |
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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.
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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. |
- 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.
- 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.
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| Ages Eligible for Study: | 21 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04576975
| Egypt | |
| Ainshams University Hospitals | |
| Cairo, Egypt, 00202 | |
| 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 |
| Responsible Party: | Belal Nabil Mahfouz Khalil, Assistant Lecturer, Ain Shams University |
| ClinicalTrials.gov Identifier: | NCT04576975 |
| Other Study ID Numbers: |
FMASU M D 108 / 2020 |
| First Posted: | October 6, 2020 Key Record Dates |
| Last Update Posted: | July 28, 2021 |
| Last Verified: | July 2021 |
| 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 |
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Obesity, Morbid Obesity Overnutrition Nutrition Disorders Overweight Body Weight Dexmedetomidine Ketamine Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Anesthetics Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents |