Ketamine Infusion vs Dexmedetomidine Infusion in Obese Patients Undergoing Bariatric Surgery

NCT04576975 | Unknown Phase 3 DMC

• 1 other identifier: FMASU M D 108 / 2020
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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 .

Conditions

Morbid Obesity; Surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  one year throughout the study

Secondary Outcomes (1)

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

  one year throughout the study

Study Arms (3)

Ketamine

EXPERIMENTAL

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

Drug: Ketamine

Dexmedetomidine

EXPERIMENTAL

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

Drug: Dexmedetomidine

Normal Saline 0.9%

PLACEBO COMPARATOR

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.

Drug: Normal Saline 0.9%

Interventions

Ketamine DRUG

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.

Ketamine

Dexmedetomidine DRUG

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.

Dexmedetomidine

Normal Saline 0.9% DRUG

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.

Normal Saline 0.9%

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead
• Ministry of Health, Kuwait: collaborator

Study Sites (1)

Ainshams University Hospitals

Cairo, 00202, Egypt

Location

Related Publications (9)

• Albaugh VL, Abumrad NN. Surgical treatment of obesity. F1000Res. 2018 May 21;7:F1000 Faculty Rev-617. doi: 10.12688/f1000research.13515.1. eCollection 2018.

  PMID: 29904577 BACKGROUND

• Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, Fainsinger R, Aass N, Kaasa S; European Palliative Care Research Collaborative (EPCRC). Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011 Jun;41(6):1073-93. doi: 10.1016/j.jpainsymman.2010.08.016.

  PMID: 21621130 BACKGROUND

• Ingrande J, Lemmens HJ. Dose adjustment of anaesthetics in the morbidly obese. Br J Anaesth. 2010 Dec;105 Suppl 1:i16-23. doi: 10.1093/bja/aeq312.

  PMID: 21148651 BACKGROUND

• Liu FL, Cherng YG, Chen SY, Su YH, Huang SY, Lo PH, Lee YY, Tam KW. Postoperative recovery after anesthesia in morbidly obese patients: a systematic review and meta-analysis of randomized controlled trials. Can J Anaesth. 2015 Aug;62(8):907-17. doi: 10.1007/s12630-015-0405-0. Epub 2015 May 22.

  PMID: 26001751 BACKGROUND

• Nonaka T, Inamori M, Miyashita T, Inoh Y, Kanoshima K, Higurashi T, Ohkubo H, Iida H, Fujita K, Kusakabe A, Gotoh T, Nakajima A. Can sedation using a combination of propofol and dexmedetomidine enhance the satisfaction of the endoscopist in endoscopic submucosal dissection? Endosc Int Open. 2018 Jan;6(1):E3-E10. doi: 10.1055/s-0043-122228. Epub 2018 Jan 12.

  PMID: 29340293 BACKGROUND

• Vaughns JD, Martin C, Nelson J, Nadler E, Quezado ZM. Dexmedetomidine as an adjuvant for perioperative pain management in adolescents undergoing bariatric surgery: An observational cohort study. J Pediatr Surg. 2017 Nov;52(11):1787-1790. doi: 10.1016/j.jpedsurg.2017.04.007. Epub 2017 Apr 19.

  PMID: 28465076 BACKGROUND

• Wang J, Echevarria GC, Doan L, Ekasumara N, Calvino S, Chae F, Martinez E, Robinson E, Cuff G, Franco L, Muntyan I, Kurian M, Schwack BF, Bedrosian AS, Fielding GA, Ren-Fielding CJ. Effects of a single subanaesthetic dose of ketamine on pain and mood after laparoscopic bariatric surgery: A randomised double-blind placebo controlled study. Eur J Anaesthesiol. 2019 Jan;36(1):16-24. doi: 10.1097/EJA.0000000000000860.

  PMID: 30095550 BACKGROUND

• Wengritzky R, Mettho T, Myles PS, Burke J, Kakos A. Development and validation of a postoperative nausea and vomiting intensity scale. Br J Anaesth. 2010 Feb;104(2):158-66. doi: 10.1093/bja/aep370. Epub 2009 Dec 26.

  PMID: 20037151 BACKGROUND

• Khalil BNM, Elderh MSH, Khaja MAR, El-Shaer AN, Ali BEEH, Taeimah MOA. Perioperative use of ketamine infusion versus dexmedetomidine infusion for analgesia in obese patients undergoing bariatric surgery: a double-blinded three-armed randomized controlled trial. BMC Anesthesiol. 2023 Apr 1;23(1):108. doi: 10.1186/s12871-023-02059-3.

  PMID: 37005580 DERIVED

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Ketamine; Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• 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

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: September 26, 2020
• First Posted: October 6, 2020
• Study Start: April 20, 2021
• Primary Completion: December 30, 2021
• Study Completion: July 1, 2022
• Last Updated: July 28, 2021

Record last verified: 2021-07

Locations

EG (1)