ObesityNCT06738043
Dexmedetomidine Versus Ketamine as Adjuvants in Bariatric Surgery
A study testing Dexmedetomidine infusion and Ketamine infusion in people with Obesity and Postoperative Pain, run by Tanta University.
Trial summary
This randomized controlled trial aims to compare the analgesic efficacy of dexmedetomidine infusion versus low-dose ketamine infusion as adjuvants in bariatric surgery. The study includes 90 patients undergoing bariatric surgery at Menoufia University Hospital, randomized into three groups: dexmedetomidine, ketamine… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Postoperative Pain, Bariatric Surgery
- What is being tested?
- Dexmedetomidine infusion and Ketamine infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2026to 20 Apr 2027
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 18-60 years.
- Both sexes.
- Body mass index (BMI) > 35 kg/m², scheduled for bariatric surgery.
- American Society of Anesthesiologists (ASA) physical status I-II.
Who cannot join
- History of hypersensitivity to dexmedetomidine or ketamine.
- History of substance abuse or chronic opioid use.
- American Society of Anesthesiologists (ASA) physical status III or IV.
- Severe hepatic or renal impairment.
- Cardiopulmonary disorders.
- Severe diabetes mellitus.
- Psychiatric disorders, seizures, uncontrolled hypertension (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg), or heart block.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Dexmedetomidine Infusion Versus Low Dose Ketamine Infusion as an Adjuvant in Bariatric Surgery: A Randomized Controlled Comparative Study
This randomized controlled trial aims to compare the analgesic efficacy of dexmedetomidine infusion versus low-dose ketamine infusion as adjuvants in bariatric surgery. The study includes 90 patients undergoing bariatric surgery at Menoufia University Hospital, randomized into three groups: dexmedetomidine, ketamine, and control (placebo). Primary outcomes include total morphine consumption intra- and post-operatively. Secondary outcomes include postoperative pain scores, total analgesic consumption, time to first analgesic request, hemodynamic parameters, and patient satisfaction. This study seeks to explore safer, more effective pain management strategies to minimize opioid use in bariatric surgery patients.
Read the detailed description
This study is a prospective, randomized controlled interventional trial evaluating the analgesic efficacy and opioid-sparing effects of dexmedetomidine and low-dose ketamine as adjuvants in bariatric surgery. Ninety patients meeting the inclusion criteria will be enrolled and randomized into three groups:
- Dexmedetomidine Group: Patients will receive a bolus dose of dexmedetomidine (0.5 µg/kg) followed by a continuous infusion (0.5 µg/kg/h) until 10 minutes before the end of surgery.
- Ketamine Group: Patients will receive a bolus dose of ketamine (0.3 mg/kg) followed by a continuous infusion (0.3 mg/kg/h) until 10 minutes before the end of surgery.
- Control Group: Patients will receive an equal volume of normal saline as a placebo.
Objectives
The primary objective is to compare intra- and postoperative morphine consumption between groups. Secondary objectives include:
- Pain assessment using the Numeric Rating Scale (NRS) at multiple time points postoperatively.
- Time to first request for rescue analgesia.
- Hemodynamic stability (heart rate and mean arterial pressure).
- Patient satisfaction assessed using a 5-point scale.
- Incidence of adverse effects such as nausea, vomiting, bradycardia, and respiratory depression.
Study Protocol All patients will undergo standard preoperative assessments, including history, physical examination, and laboratory investigations. General anesthesia will be induced and maintained per institutional protocols. Postoperatively, pain management will follow a stepwise approach, with intravenous paracetamol as rescue analgesia.
Significance Given the high prevalence of obesity-related comorbidities, bariatric surgery patients are at increased risk for postoperative complications, particularly with opioid use. This study addresses the need for opioid-sparing pain management strategies, potentially reducing the risks of opioid-related adverse effects and improving patient outcomes.
- Conditions
- Obesity, Postoperative Pain, Bariatric Surgery
- Being tested
- Dexmedetomidine infusion, Ketamine infusion, Normal Saline Infusion (Placebo)
- Keywords
- Dexmedetomidine, Ketamine, Opioid-Sparing Analgesia, Randomized Controlled Trial, Pain Management
- Medical subject headings
- Obesity, Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine infusionDrug
A bolus dose of dexmedetomidine (0.5 µg/kg ideal body weight) diluted in 0.9% normal saline is infused over 10 minutes before induction of anesthesia, followed by a continuous infusion at 0.5 µg/kg/h until 10 minutes before the end of surgery.
Ketamine infusionDrug
A bolus dose of ketamine (0.3 mg/kg ideal body weight) diluted in 0.9% normal saline is infused over 10 minutes before induction of anesthesia, followed by a continuous infusion at 0.3 mg/kg/h until 10 minutes before the end of surgery.
Normal Saline Infusion (Placebo)Drug
A bolus dose of 0.9% normal saline is infused over 10 minutes before induction of anesthesia, followed by a continuous infusion of 0.9% normal saline until 10 minutes before the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Group | Experimental | Participants in this group will receive a bolus dose of dexmedetomidine (0.5 µg/kg ideal body weight) diluted in 0.9% normal saline over 10 minutes before induction of anesthesia. This will be followed by a continuous infusion of dexmedetomidine at 0.5 µg/kg/h until 10 minutes before the end of surgery. Receives: Drug: Dexmedetomidine infusion |
| Ketamine Group | Experimental | Participants in this group will receive a bolus dose of ketamine (0.3 mg/kg ideal body weight) diluted in 0.9% normal saline over 10 minutes before induction of anesthesia. This will be followed by a continuous infusion of ketamine at 0.3 mg/kg/h until 10 minutes before the end of surgery. Receives: Drug: Ketamine infusion |
| Control Group | Placebo comparator | Participants in this group will receive a bolus dose of 0.9% normal saline over 10 minutes before induction of anesthesia. This will be followed by a continuous infusion of 0.9% normal saline until 10 minutes before the end of surgery. Receives: Drug: Normal Saline Infusion (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Total Morphine Consumption
The total dose of morphine, measured in mg, administered to each participant during the first 24 hours postoperatively for pain control.
Measured: Within the first 24 hours postoperatively
Secondary outcomes (7)
Postoperative Pain Scores (Numeric Rating Scale - NRS)
Pain intensity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Pain scores will be recorded at specific intervals postoperatively (1, 2, 4, 8, 12, 16, and 24 hours).
Measured: At 1, 2, 4, 8, 12, 16, and 24 hours postoperatively
Time to First Request for Rescue Analgesia
The duration (in hours) from the end of surgery to the first request for rescue analgesia (intravenous morphine) by the participant.
Measured: 24 hours postoperatively
Hemodynamic Stability (Heart Rate)
Heart rate (HR) will be monitored and recorded at specific intervals during and after surgery to assess hemodynamic stability.
Measured: From baseline (pre-surgery) to 24 hours postoperatively
Hemodynamic Stability (Mean Arterial Pressure)
Mean arterial pressure (MAP) will be monitored and recorded at specific intervals during and after surgery to assess hemodynamic stability.
Measured: From baseline (pre-surgery) to 24 hours postoperatively
Total Analgesic Consumption (Other Than Morphine)
The total dose of non-morphine analgesics (e.g., paracetamol) administered postoperatively to manage pain within the first 24 hours after surgery.
Measured: At 24 hours postoperatively
Patient Satisfaction with Pain Management
Patient satisfaction will be assessed using a 5-point Likert scale (1 = highly satisfied, 2 = satisfied, 3 = neutral, 4 = unsatisfied, 5 = highly unsatisfied) based on their postoperative pain management experience.
Measured: At 24 hours postoperatively
Intraoperative Fentanyl Consumption
The total dose of fentanyl, measured in µg, administered intraoperatively during anesthesia maintenance.
Measured: Intraoperatively (From induction of anesthesia until the end of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start20 Apr 2026 (estimated)
- Primary completion20 Apr 2027 (estimated)
- Study completion20 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized into three parallel groups: dexmedetomidine, ketamine, or control (placebo) groups, each receiving specific interventions based on the protocol.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdalla Shalaby, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738043
- Sponsor's protocol ID
- 11/2024ANET15
- Status last verified
- Apr 2026
- First submitted
- 12 Dec 2024
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Infusion Versus Low Dose Ketamine Infusion as an Adjuvant in Bariatric Surgery: A Randomized Controlled Comparative Study
- ClinicalTrials.gov ID
- NCT06738043
- Acronym / sponsor ID
- 11/2024ANET15
- Conditions
- Obesity, Postoperative Pain, Bariatric Surgery
- Keywords
- Dexmedetomidine, Ketamine, Opioid-Sparing Analgesia, Randomized Controlled Trial, Pain Management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 20 Apr 2027 (estimated)
- Study completion
- 20 Apr 2027 (estimated)
- First posted
- 17 Dec 2024 (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.
This randomized controlled trial aims to compare the analgesic efficacy of dexmedetomidine infusion versus low-dose ketamine infusion as adjuvants in bariatric surgery. The study includes 90 patients undergoing bariatric surgery at Menoufia University Hospital, randomized into three groups: dexmedetomidine, ketamine, and control (placebo). Primary outcomes include total morphine consumption intra- and post-operatively. Secondary outcomes include postoperative pain scores, total analgesic consumption, time to first analgesic request, hemodynamic parameters, and patient satisfaction. This study seeks to explore safer, more effective pain management strategies to minimize opioid use in bariatric surgery patients.
Detailed description
This study is a prospective, randomized controlled interventional trial evaluating the analgesic efficacy and opioid-sparing effects of dexmedetomidine and low-dose ketamine as adjuvants in bariatric surgery. Ninety patients meeting the inclusion criteria will be enrolled and randomized into three groups:
- Dexmedetomidine Group: Patients will receive a bolus dose of dexmedetomidine (0.5 µg/kg) followed by a continuous infusion (0.5 µg/kg/h) until 10 minutes before the end of surgery.
- Ketamine Group: Patients will receive a bolus dose of ketamine (0.3 mg/kg) followed by a continuous infusion (0.3 mg/kg/h) until 10 minutes before the end of surgery.
- Control Group: Patients will receive an equal volume of normal saline as a placebo.
Objectives
The primary objective is to compare intra- and postoperative morphine consumption between groups. Secondary objectives include:
- Pain assessment using the Numeric Rating Scale (NRS) at multiple time points postoperatively.
- Time to first request for rescue analgesia.
- Hemodynamic stability (heart rate and mean arterial pressure).
- Patient satisfaction assessed using a 5-point scale.
- Incidence of adverse effects such as nausea, vomiting, bradycardia, and respiratory depression.
Study Protocol All patients will undergo standard preoperative assessments, including history, physical examination, and laboratory investigations. General anesthesia will be induced and maintained per institutional protocols. Postoperatively, pain management will follow a stepwise approach, with intravenous paracetamol as rescue analgesia.
Significance Given the high prevalence of obesity-related comorbidities, bariatric surgery patients are at increased risk for postoperative complications, particularly with opioid use. This study addresses the need for opioid-sparing pain management strategies, potentially reducing the risks of opioid-related adverse effects and improving patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Patients will be randomized into three parallel groups: dexmedetomidine, ketamine, or control (placebo) groups, each receiving specific interventions based on the protocol.
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Group | Experimental | Drug: Dexmedetomidine infusionParticipants in this group will receive a bolus dose of dexmedetomidine (0.5 µg/kg ideal body weight) diluted in 0.9% normal saline over 10 minutes before induction of anesthesia. This will be followed by a continuous infusion of dexmedetomidine at 0.5 µg/kg/h until 10 minutes before the end of surgery. |
| Ketamine Group | Experimental | Drug: Ketamine infusionParticipants in this group will receive a bolus dose of ketamine (0.3 mg/kg ideal body weight) diluted in 0.9% normal saline over 10 minutes before induction of anesthesia. This will be followed by a continuous infusion of ketamine at 0.3 mg/kg/h until 10 minutes before the end of surgery. |
| Control Group | Placebo comparator | Drug: Normal Saline Infusion (Placebo)Participants in this group will receive a bolus dose of 0.9% normal saline over 10 minutes before induction of anesthesia. This will be followed by a continuous infusion of 0.9% normal saline until 10 minutes before the end of surgery. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged 18-60 years.
- Both sexes.
- Body mass index (BMI) > 35 kg/m², scheduled for bariatric surgery.
- American Society of Anesthesiologists (ASA) physical status I-II.
Key exclusion criteria (7 listed)
- History of hypersensitivity to dexmedetomidine or ketamine.
- History of substance abuse or chronic opioid use.
- American Society of Anesthesiologists (ASA) physical status III or IV.
- Severe hepatic or renal impairment.
- Cardiopulmonary disorders.
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 |
|---|---|---|
| Dexmedetomidine infusionA bolus dose of dexmedetomidine (0.5 µg/kg ideal body weight) diluted in 0.9% normal saline is infused over 10 minutes before induction of anesthesia, followed by a continuous infusion at 0.5 µg/kg/h until 10 minutes before the end of surgery. | Drug | Dexmedetomidine Group |
| Ketamine infusionA bolus dose of ketamine (0.3 mg/kg ideal body weight) diluted in 0.9% normal saline is infused over 10 minutes before induction of anesthesia, followed by a continuous infusion at 0.3 mg/kg/h until 10 minutes before the end of surgery. | Drug | Ketamine Group |
| Normal Saline Infusion (Placebo)A bolus dose of 0.9% normal saline is infused over 10 minutes before induction of anesthesia, followed by a continuous infusion of 0.9% normal saline until 10 minutes before the end of surgery. | Drug | Control Group |
Primary outcome
Postoperative Total Morphine Consumption
Time frame: Within the first 24 hours postoperatively
The total dose of morphine, measured in mg, administered to each participant during the first 24 hours postoperatively for pain control.
7 secondary outcomes
Postoperative Pain Scores (Numeric Rating Scale - NRS)
Time frame: At 1, 2, 4, 8, 12, 16, and 24 hours postoperatively
Time to First Request for Rescue Analgesia
Time frame: 24 hours postoperatively
Hemodynamic Stability (Heart Rate)
Time frame: From baseline (pre-surgery) to 24 hours postoperatively
Hemodynamic Stability (Mean Arterial Pressure)
Time frame: From baseline (pre-surgery) to 24 hours postoperatively
Total Analgesic Consumption (Other Than Morphine)
Time frame: At 24 hours postoperatively
Patient Satisfaction with Pain Management
Time frame: At 24 hours postoperatively
Intraoperative Fentanyl Consumption
Time frame: Intraoperatively (From induction of anesthesia until the end of surgery)
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 9 Apr 2026.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine infusion and Ketamine infusion in people with Obesity and Postoperative Pain, run by Tanta University.
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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Contact Ahmed A Shalaby, M.B.B.Ch (01020479848 ext. +2, phdoc97@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Total Morphine Consumption (time frame: Within 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 9 Apr 2026.