Morbid ObesityKetodexNCT07246447
Ketodex Versus Opioid Based Anesthesia in Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy.
A study testing ketamine and dexmeditomidine combination and Fentanyl (IV) in people with Morbid Obesity, run by Cairo University at 1 site in Egypt.
Trial summary
comparing Opioid sparing anesthesia using ketodex versus opioid based anesthesia in obese patients undergoing laparoscopic sleeve gastrectomy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- ketamine and dexmeditomidine combination and Fentanyl (IV)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Nov 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients (>18 years) undergoing Elective Bariatric Surgery .
- American Society of Anesthesiologists physical status class II or III .
- body mass index (BMI) > 35 kg/m2 .
Who cannot join
- • Refusal to participate .
- Any sensitivity or contraindication to ketamine or dexmedotomidine .
- Pregnancy or breast feeding .
- Patients with significant renal impairment .
- Any patient on regular intake of beta blockers or calcium channel blockers .
- CNS disorders eg: seizures , raised intra cranial tension .
- Chronic opioid use.
- Obese patients with STOP bang score more than 5 .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Opioid Sparing Anesthesia Using Ketodex Versus Opioid Based Anesthesia in Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy: A Randomized Controlled Trial.
comparing Opioid sparing anesthesia using ketodex versus opioid based anesthesia in obese patients undergoing laparoscopic sleeve gastrectomy.
Read the detailed description
Bariatric surgery has seen a substantial increase, especially among patients with medically complex obesity who struggle to lose weight with traditional approaches . Although advances in anesthetic procedures enhance surgical and clinical outcomes, regular opioid usage in bariatric surgeries might result in adverse effects such as drowsiness, postoperative nausea and vomiting (PONV), respiratory depression, and impaired gastrointestinal motility. These adverse effects increase the risk of postoperative cardiac and respiratory complications .
The key to managing such patients is the utilization of a novel form of anesthesia and analgesia, known as opioid-sparing anesthesia, which has recently been developed to ensure better outcomes . During opioid-sparing anesthesia, the sympathetic nervous system is inhibited by means other than opioid delivery . Such techniques include the use of medications from the alpha-2 agonist group, lidocaine, ketamine, magnesium sulfate, beta-blockers, or gabapentinoids .
Ketamine is an N-methyl-D-aspartate antagonist with analgesic and anti-hyperalgesic properties at low doses . This drug prevents the development of opioid tolerance by minimizing opioid use while reducing postoperative pain, ultimately decreasing opioid-related postoperative morbidity .
Dexmedetomidine, a highly selective α2-adrenoceptor agonist, is used as an adjuvant analgesic in the perioperative period . It improves hemodynamic stability and reduces the stress induced by intubation due to its central sympatholytic action . Furthermore, it decreases the need for opioids and anesthetics, providing additional benefits for obese patients .
By lowering the required dosages, adding a low dose of ketamine to dexmedetomidine is thought to result in less toxicity than using either medication alone . Vishnuraj et al. concluded that the combination of ketamine and dexmedetomidine effectively reduced postoperative opioid consumption; however, their approach involved the use of ketamine as a bolus following induction, in conjunction with a continuous infusion of dexmedetomidine in adults undergoing laparoscopic cholecystectomy .
To the best of our knowledge, the use of both ketamine and dexmedetomidine infusion versus opioid-based anesthesia among patients undergoing bariatric surgery, specifically regarding postoperative pain, has not been previously compared
- Conditions
- Morbid Obesity
- Being tested
- ketamine and dexmeditomidine combination, Fentanyl (IV)
- Keywords
- ketamine, dexmedatodine, obesity, sleeve gastrectomy
- Medical subject headings
- Obesity, Morbid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketamine and dexmeditomidine combinationDrug
Also called ketodex
Group KD: Two syringes containing ketodex-ketamine (1 mg/kg) and dexmedetomidine (1 µg/kg)-each diluted with 0.9% saline and infused over 10 minutes. Maintenance will consist of continuous low-dose infusion of ketamine (0.3 mg/kg/h) and dexmedetomidine (0.5 µg/kg/h) in separate syringes until 15 minutes before the end of surgery.
Fentanyl (IV)Drug
Also called opioiod based anesthesia
Group OP: Two syringes-one containing fentanyl (2 µg/kg) and the other 0.9% saline-infused over 10 minutes. Maintenance will be provided by two continuous saline infusions, prepared to mimic the ketodex infusions, until 15 minutes before the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| ketodex group | Active comparator | Group KD: Two syringes containing ketodex-ketamine (1 mg/kg) and dexmedetomidine (1 µg/kg)-each diluted with 0.9% saline and infused over 10 minutes. Maintenance will consist of continuous low-dose infusion of ketamine (0.3 mg/kg/h) and dexmedetomidine (0.5 µg/kg/h) in separate syringes until 15 minutes before the end of surgery. Receives: Drug: ketamine and dexmeditomidine combination |
| opioid based group | Active comparator | Group OP: Two syringes-one containing fentanyl (2 µg/kg) and the other 0.9% saline-infused over 10 minutes. Maintenance will be provided by two continuous saline infusions, prepared to mimic the ketodex infusions, until 15 minutes before the end of surgery. Receives: Drug: Fentanyl (IV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total nalbuphine consumption (mg) during the first 24 hours postoperatively.
Total nalbuphine consumption (mg) during the first 24 hours postoperatively.
Measured: during the first 24 hours postoperatively
Secondary outcomes (8)
Total intraoperative titrated fentanyl dose for each patient.
Measured: intraoperative time
Time to extubation, defined as the interval between discontinuation of anesthesia and tracheal extubation
Measured: the interval between discontinuation of anesthesia and tracheal extubation
• Time to first postoperative rescue analgesia
Measured: during 1st 24 hrs postoperatively.
Postoperative sedation scores.
Sedation assessment: All patients will be monitored postoperatively in the post-anesthesia care unit (PACU) and ward. Sedation will be assessed using the Modified Observer's Assessment of Alertness/Sedation Scale (MOASS) . Scores will be recorded at 0, 10, 30, and 60 minutes from PACU admission.
Measured: 1st 24 hours postoperatively
Postoperative pain scores assessed using the Numerical Rating Scale (NRS).
Postoperative pain: Pain will be assessed using the Numerical Rating Scale (NRS, 0 = no pain, 10 = worst pain). Patients will be instructed preoperatively regarding the scale. NRS scores will be recorded at 0, 30, and 60 minutes, and at 2, 6, 12, and 24 hours after surgery.
Measured: 1st 24 hours post operatively
Postoperative nausea and vomiting (PONV) scores
by using Simplified PONV Impact Scale (SPONVIS) This simplified version, often used for audit and post-discharge review, uses just two main components: Nausea Impact and Vomiting Impact.
- Nausea Impact," Based on the patient's assessment of how much the nausea affected their recovery (e.g., ability to eat, walk, or be discharged).","0 to 5 Points (e.g., 0 = No Impact, 5 = Severe Impact/Required hospital stay)"
- Vomiting/Retching, Total number of vomiting or retching episodes.,"0 to 5 Points (e.g., 0 = None, 5 = ≥3 episodes)" Total SPONVIS Score Sum of Nausea Impact + Vomiting/Retching Points, Score: 0 to 10 Cut-off for CIPONV Total Score ≥5
Measured: 1st 24 hours postoperatively
Patient satisfaction scores .
(0 = not satisfied, 10 = highly satisfied).
Measured: during 1st 24 hours postoperatively.
Length of hospital stay
From date of randomization until the date of first documented progression
Measured: 1-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start11 Nov 2025
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Kasr El Aini Hospital
- Responsible party
- Principal investigator, Mai younes Taha, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246447
- Sponsor's protocol ID
- ketodex in obesity
- Acronym
- Ketodex
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Sparing Anesthesia Using Ketodex Versus Opioid Based Anesthesia in Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07246447
- Acronym / sponsor ID
- Ketodex / ketodex in obesity
- Conditions
- Morbid Obesity
- Keywords
- ketamine, dexmedatodine, obesity, sleeve gastrectomy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Kasr El Aini Hospital
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
comparing Opioid sparing anesthesia using ketodex versus opioid based anesthesia in obese patients undergoing laparoscopic sleeve gastrectomy.
Detailed description
Bariatric surgery has seen a substantial increase, especially among patients with medically complex obesity who struggle to lose weight with traditional approaches . Although advances in anesthetic procedures enhance surgical and clinical outcomes, regular opioid usage in bariatric surgeries might result in adverse effects such as drowsiness, postoperative nausea and vomiting (PONV), respiratory depression, and impaired gastrointestinal motility. These adverse effects increase the risk of postoperative cardiac and respiratory complications .
The key to managing such patients is the utilization of a novel form of anesthesia and analgesia, known as opioid-sparing anesthesia, which has recently been developed to ensure better outcomes . During opioid-sparing anesthesia, the sympathetic nervous system is inhibited by means other than opioid delivery . Such techniques include the use of medications from the alpha-2 agonist group, lidocaine, ketamine, magnesium sulfate, beta-blockers, or gabapentinoids .
Ketamine is an N-methyl-D-aspartate antagonist with analgesic and anti-hyperalgesic properties at low doses . This drug prevents the development of opioid tolerance by minimizing opioid use while reducing postoperative pain, ultimately decreasing opioid-related postoperative morbidity .
Dexmedetomidine, a highly selective α2-adrenoceptor agonist, is used as an adjuvant analgesic in the perioperative period . It improves hemodynamic stability and reduces the stress induced by intubation due to its central sympatholytic action . Furthermore, it decreases the need for opioids and anesthetics, providing additional benefits for obese patients .
By lowering the required dosages, adding a low dose of ketamine to dexmedetomidine is thought to result in less toxicity than using either medication alone . Vishnuraj et al. concluded that the combination of ketamine and dexmedetomidine effectively reduced postoperative opioid consumption; however, their approach involved the use of ketamine as a bolus following induction, in conjunction with a continuous infusion of dexmedetomidine in adults undergoing laparoscopic cholecystectomy .
To the best of our knowledge, the use of both ketamine and dexmedetomidine infusion versus opioid-based anesthesia among patients undergoing bariatric surgery, specifically regarding postoperative pain, has not been previously compared
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ketodex group | Active comparator | Drug: ketamine and dexmeditomidine combinationGroup KD: Two syringes containing ketodex-ketamine (1 mg/kg) and dexmedetomidine (1 µg/kg)-each diluted with 0.9% saline and infused over 10 minutes. Maintenance will consist of continuous low-dose infusion of ketamine (0.3 mg/kg/h) and dexmedetomidine (0.5 µg/kg/h) in separate syringes until 15 minutes before the end of surgery. |
| opioid based group | Active comparator | Drug: Fentanyl (IV)Group OP: Two syringes-one containing fentanyl (2 µg/kg) and the other 0.9% saline-infused over 10 minutes. Maintenance will be provided by two continuous saline infusions, prepared to mimic the ketodex infusions, until 15 minutes before the end of surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (>18 years) undergoing Elective Bariatric Surgery .
Key exclusion criteria (8 listed)
- • Refusal to participate .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ketamine and dexmeditomidine combinationAlso: ketodexGroup KD: Two syringes containing ketodex-ketamine (1 mg/kg) and dexmedetomidine (1 µg/kg)-each diluted with 0.9% saline and infused over 10 minutes. Maintenance will consist of continuous low-dose infusion of ketamine (0.3 mg/kg/h) and dexmedetomidine (0.5 µg/kg/h) in separate syringes until 15 minutes before the end of surgery. | Drug | ketodex group |
| Fentanyl (IV)Also: opioiod based anesthesiaGroup OP: Two syringes-one containing fentanyl (2 µg/kg) and the other 0.9% saline-infused over 10 minutes. Maintenance will be provided by two continuous saline infusions, prepared to mimic the ketodex infusions, until 15 minutes before the end of surgery. | Drug | opioid based group |
Primary outcome
Total nalbuphine consumption (mg) during the first 24 hours postoperatively.
Time frame: during the first 24 hours postoperatively
Total nalbuphine consumption (mg) during the first 24 hours postoperatively.
8 secondary outcomes
Total intraoperative titrated fentanyl dose for each patient.
Time frame: intraoperative time
Time to extubation, defined as the interval between discontinuation of anesthesia and tracheal extubation
Time frame: the interval between discontinuation of anesthesia and tracheal extubation
• Time to first postoperative rescue analgesia
Time frame: during 1st 24 hrs postoperatively.
Postoperative sedation scores.
Time frame: 1st 24 hours postoperatively
Postoperative pain scores assessed using the Numerical Rating Scale (NRS).
Time frame: 1st 24 hours post operatively
Postoperative nausea and vomiting (PONV) scores
Time frame: 1st 24 hours postoperatively
Patient satisfaction scores .
Time frame: during 1st 24 hours postoperatively.
Length of hospital stay
Time frame: 1-2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
Related trials for Morbid Obesity
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Not yet recruitingObservational study
Evaluating Metabolic Health in Individuals With Extreme Obesity
BMI>40
Enrolling by invitationObservational study
Bariatric Surgery Registry
Obesity, Morbid
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Active, not recruiting
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Obesity, Morbid, Eating Disorder Symptom
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ketamine and dexmeditomidine combination and Fentanyl (IV) in people with Morbid Obesity, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total nalbuphine consumption (mg) during the first 24 hours postoperatively. (time frame: during the first 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.