Morbid ObesityNCT04836819
Analgesia Management in Bariatric Surgery
A study testing Lidocain, Ketamine and Dexmedetomidine in people with Morbid Obesity and Bariatric Surgery Candidate, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
Following laparoscopic bariatric surgery, multimodal analgesia is recommended to avoid the adverse effects of opioids by reducing their use. Although lidocaine, ketamine, and dexmedetomidine have been used as adjuvant analgesics, no studies have evaluated the superiority of their intra- and postoperative infusions as… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity, Bariatric Surgery Candidate, Pain
- What is being tested?
- Lidocain, Ketamine and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Apr 2021to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index>35 kg/m2
- The American Society of Anaesthesiologists (ASA) physical status class II III
- Patients who will undergo an elective laparoscopic sleeve gastrectomy (LSG)
Who cannot join
- refusal to participate
- allergy to the study drugs
- chronic kidney disease (creatinine>150 μmol/L)
- mental illness
- liver, respiratory or oncological disease,
- cardiac dysfunction (ejection fraction <40%),
Show all 10Show fewer
- uncontrolled hypertension,
- preoperative analgesic use,
- chronic pain,
- history of alcohol or drug addiction
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayis University
Samsun, Atakum, 55270
About this study
Official title: Comparison of Lidocaine, Dexmedetomidine and Ketamine in Multimodal Analgesia Management Following Sleeve Gastrectomy Surgery: A Randomized Double-Blind Trial
Following laparoscopic bariatric surgery, multimodal analgesia is recommended to avoid the adverse effects of opioids by reducing their use. Although lidocaine, ketamine, and dexmedetomidine have been used as adjuvant analgesics, no studies have evaluated the superiority of their intra- and postoperative infusions as components of multimodal analgesia in bariatric surgery. The present study is aimed to compare lidocaine, dexmedetomidine, and ketamine in multimodal analgesia management following Sleeve Gastrectomy Surgery. Postoperative pain scores, the requirement for additional postoperative analgesia, retching, nausea and vomiting, time to mobilization, and hospital length of stay will be evaluated.
Read the detailed description
Patients will be divided into three groups.
Group L: The patients will receive intravenous lidocaine (2 mg/kg/h) immediately after anesthesia induction. At the end of the surgery, the dose will be decreased to 1 mg/kg/h. The infusion will continue until 12 hours after the operation.
Group K: The patients will receive intravenous ketamine (0.5 mg/kg/h) immediately after anesthesia induction. At the end of the surgery, the dose will be decreased to 0.3 mg/kg/h. The infusion will continue until 12 hours after the operation.
Group D: The patients will receive intravenous dexmedetomidine (0.5 mg/kg/h) immediately after anesthesia induction. At the end of the surgery, the dose will be decreased to 0.3 mg/kg/h. The infusion will continue until 12 hours after the operation.
Ketamine, lidocaine, and dexmedetomidine doses will be calculated according to ideal body weight, lean body weight, and actual body weight, respectively.
Randomization will be performed using a computer-generated random number list, and a statement indicating the patient's group will be placed in a closed envelope numbered according to the result. Each patient will be asked to choose an envelope, and the patients will be assigned to the study according to the group mentioned in the envelope.
- Conditions
- Morbid Obesity, Bariatric Surgery Candidate, Pain, Postoperative
- Being tested
- Lidocain, Ketamine, Dexmedetomidine
- Keywords
- Dexmedetomidine, Ketamine, Lidocaine, Obesity, Morbid, Pain, Postoperative
- Medical subject headings
- Obesity, Morbid, Pain, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocainDrug
IV lidocaine infusion (2 mg/kg/h) will be initiated after anesthesia induction and decrease the dosage to 1 mg/kg/h at the end of surgery. The infusion will continue until 12 hours after the operation.1 g paracetamol, 100 mg tramadol, 100 mg ketoprofen, and 4 mg dexamethasone will be administered to all patients pre-emptively. Granisetron (3 mg) will be administered 30 minutes before the end of surgery. In the postoperative period, i.v. Paracetamol will be administered at 8-hour intervals and 25-50 mg meperidine i.m. (maximum dose 200 mg) as rescue analgesia when requested by the patient and if VAS>4.
KetamineDrug
IV ketamine infusion (0.5 mg/kg/h) will be initiated after anesthesia induction and decrease the dosage to 0.3 mg/kg/h at the end of surgery. The infusion will continue until 12 hours after the operation.1 g paracetamol, 100 mg tramadol, 100 mg ketoprofen, and 4 mg dexamethasone will be administered to all patients pre-emptively. Granisetron (3 mg) will be administered 30 minutes before the end of surgery. In the postoperative period, i.v. Paracetamol will be administered at 8-hour intervals and 25-50 mg meperidine i.m. (maximum dose 200 mg) as rescue analgesia when requested by the patient and if VAS>4.
DexmedetomidineDrug
IV dexmedetomidine infusion (0.5 mg/kg/h) will be initiated after anesthesia induction and decrease the dosage to 0.3 mg/kg/h at the end of surgery. The infusion will continue until 12 hours after the operation.1 g paracetamol, 100 mg tramadol, 100 mg ketoprofen, and 4 mg dexamethasone will be administered to all patients pre-emptively. Granisetron (3 mg) will be administered 30 minutes before the end of surgery. In the postoperative period, i.v. Paracetamol will be administered at 8-hour intervals and 25-50 mg meperidine i.m. (maximum dose 200 mg) as rescue analgesia when requested by the patient and if VAS>4.
| Study group | Role | What they receive |
|---|---|---|
| Group L | Active comparator | IV lidocaine infusion (1-2 mg/kg/h) up to postoperative 12 hours. Receives: Drug: Lidocain |
| Group K | Active comparator | IV ketamine infusion (0.3-0.5 mg/kg/h) up to postoperative 12 hours. Receives: Drug: Ketamine |
| Group D | Active comparator | IV dexmedetomidine infusion (0.3-0.5 mg/kg/h) up to postoperative 12 hours. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain: VAS scores at rest and movement
Pain status at rest and movement will be assessed by VAS scores. The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (worst pain imaginable).
Measured: Up to 15 days after the surgery.
Secondary outcomes (4)
Postoperative Rescue Analgesic Requirement
After the end of surgery 25-50 mg meperidine (maximum dose 200 mg) will be administered i.m. as rescue analgesia when requested by the patient and if VAS>4. the Rescue analgesic dosage will be recorded.
Measured: Up to three days after surgery
Postoperative nausea, retching and vomiting
The number of patients who has complained of nausea, retching and vomiting will be recorded.
Measured: Up to 3 days after surgery.
Time to first mobilization
The patients first mobilization time after the operation will be recorded.
Measured: Up to 24 hours after surgery.
Time to discharge
The length of hospital stay will be recorded.
Measured: Trough hospital stay, an average of 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start8 Apr 2021
- Primary completion5 Jun 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- Model description
- The patients will be randomly classified into three groups.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Burcu Ustun, Ondokuz Mayıs University
- Investigators
- Ersin Koksal, Principal investigator, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836819
- Sponsor's protocol ID
- SGPAM-DKL11
- Status last verified
- Jul 2021
- First submitted
- 5 Apr 2021
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Belcaid I, Eipe N. Perioperative Pain Management in Morbid Obesity. Drugs. 2019 Jul;79(11):1163-1175. doi: 10.1007/s40265-019-01156-3.
PubMed 31256367Feld JM, Hoffman WE, Stechert MM, Hoffman IW, Ananda RC. Fentanyl or dexmedetomidine combined with desflurane for bariatric surgery. J Clin Anesth. 2006 Feb;18(1):24-8. doi: 10.1016/j.jclinane.2005.05.009.
PubMed 16517328Laskowski K, Stirling A, McKay WP, Lim HJ. A systematic review of intravenous ketamine for postoperative analgesia. Can J Anaesth. 2011 Oct;58(10):911-23. doi: 10.1007/s12630-011-9560-0. Epub 2011 Jul 20.
PubMed 21773855Ciftci B, Ekinci M, Celik EC, Kaciroglu A, Karakaya MA, Demiraran Y, Ozdenkaya Y. Comparison of Intravenous Ibuprofen and Paracetamol for Postoperative Pain Management after Laparoscopic Sleeve Gastrectomy. A Randomized Controlled Study. Obes Surg. 2019 Mar;29(3):765-770. doi: 10.1007/s11695-018-3613-1.
PubMed 30474791Bamgbade OA, Oluwole O, Khaw RR. Perioperative Analgesia for Fast-Track Laparoscopic Bariatric Surgery. Obes Surg. 2017 Jul;27(7):1828-1834. doi: 10.1007/s11695-017-2562-4.
PubMed 28120147
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Lidocaine, Dexmedetomidine and Ketamine in Multimodal Analgesia Management Following Sleeve Gastrectomy Surgery: A Randomized Double-Blind Trial
- ClinicalTrials.gov ID
- NCT04836819
- Acronym / sponsor ID
- SGPAM-DKL11
- Conditions
- Morbid Obesity, Bariatric Surgery Candidate, Pain, Postoperative
- Keywords
- Dexmedetomidine, Ketamine, Lidocaine, Obesity, Morbid, Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 5 Jun 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 8 Apr 2021 (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.
Following laparoscopic bariatric surgery, multimodal analgesia is recommended to avoid the adverse effects of opioids by reducing their use. Although lidocaine, ketamine, and dexmedetomidine have been used as adjuvant analgesics, no studies have evaluated the superiority of their intra- and postoperative infusions as components of multimodal analgesia in bariatric surgery. The present study is aimed to compare lidocaine, dexmedetomidine, and ketamine in multimodal analgesia management following Sleeve Gastrectomy Surgery. Postoperative pain scores, the requirement for additional postoperative analgesia, retching, nausea and vomiting, time to mobilization, and hospital length of stay will be evaluated.
Detailed description
Patients will be divided into three groups.
Group L: The patients will receive intravenous lidocaine (2 mg/kg/h) immediately after anesthesia induction. At the end of the surgery, the dose will be decreased to 1 mg/kg/h. The infusion will continue until 12 hours after the operation.
Group K: The patients will receive intravenous ketamine (0.5 mg/kg/h) immediately after anesthesia induction. At the end of the surgery, the dose will be decreased to 0.3 mg/kg/h. The infusion will continue until 12 hours after the operation.
Group D: The patients will receive intravenous dexmedetomidine (0.5 mg/kg/h) immediately after anesthesia induction. At the end of the surgery, the dose will be decreased to 0.3 mg/kg/h. The infusion will continue until 12 hours after the operation.
Ketamine, lidocaine, and dexmedetomidine doses will be calculated according to ideal body weight, lean body weight, and actual body weight, respectively.
Randomization will be performed using a computer-generated random number list, and a statement indicating the patient's group will be placed in a closed envelope numbered according to the result. Each patient will be asked to choose an envelope, and the patients will be assigned to the study according to the group mentioned in the envelope.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- The patients will be randomly classified into three groups.
| Arm | Type | Receives |
|---|---|---|
| Group L | Active comparator | Drug: LidocainIV lidocaine infusion (1-2 mg/kg/h) up to postoperative 12 hours. |
| Group K | Active comparator | Drug: KetamineIV ketamine infusion (0.3-0.5 mg/kg/h) up to postoperative 12 hours. |
| Group D | Active comparator | Drug: DexmedetomidineIV dexmedetomidine infusion (0.3-0.5 mg/kg/h) up to postoperative 12 hours. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body mass index>35 kg/m2
- The American Society of Anaesthesiologists (ASA) physical status class II III
- Patients who will undergo an elective laparoscopic sleeve gastrectomy (LSG)
Key exclusion criteria (10 listed)
- refusal to participate
- allergy to the study drugs
- chronic kidney disease (creatinine>150 μmol/L)
- mental illness
- liver, respiratory or oncological disease,
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 |
|---|---|---|
| LidocainIV lidocaine infusion (2 mg/kg/h) will be initiated after anesthesia induction and decrease the dosage to 1 mg/kg/h at the end of surgery. The infusion will continue until 12 hours after the operation.1 g paracetamol, 100 mg tramadol, 100 mg ketoprofen, and 4 mg dexamethasone will be administered to all patients pre-emptively. Granisetron (3 mg) will be administered 30 minutes before the end of surgery. In the postoperative period, i.v. Paracetamol will be administered at 8-hour intervals and 25-50 mg meperidine i.m. (maximum dose 200 mg) as rescue analgesia when requested by the patient and if VAS>4. | Drug | Group L |
| KetamineIV ketamine infusion (0.5 mg/kg/h) will be initiated after anesthesia induction and decrease the dosage to 0.3 mg/kg/h at the end of surgery. The infusion will continue until 12 hours after the operation.1 g paracetamol, 100 mg tramadol, 100 mg ketoprofen, and 4 mg dexamethasone will be administered to all patients pre-emptively. Granisetron (3 mg) will be administered 30 minutes before the end of surgery. In the postoperative period, i.v. Paracetamol will be administered at 8-hour intervals and 25-50 mg meperidine i.m. (maximum dose 200 mg) as rescue analgesia when requested by the patient and if VAS>4. | Drug | Group K |
| DexmedetomidineIV dexmedetomidine infusion (0.5 mg/kg/h) will be initiated after anesthesia induction and decrease the dosage to 0.3 mg/kg/h at the end of surgery. The infusion will continue until 12 hours after the operation.1 g paracetamol, 100 mg tramadol, 100 mg ketoprofen, and 4 mg dexamethasone will be administered to all patients pre-emptively. Granisetron (3 mg) will be administered 30 minutes before the end of surgery. In the postoperative period, i.v. Paracetamol will be administered at 8-hour intervals and 25-50 mg meperidine i.m. (maximum dose 200 mg) as rescue analgesia when requested by the patient and if VAS>4. | Drug | Group D |
Primary outcome
Postoperative pain: VAS scores at rest and movement
Time frame: Up to 15 days after the surgery.
Pain status at rest and movement will be assessed by VAS scores. The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (worst pain imaginable).
4 secondary outcomes
Postoperative Rescue Analgesic Requirement
Time frame: Up to three days after surgery
Postoperative nausea, retching and vomiting
Time frame: Up to 3 days after surgery.
Time to first mobilization
Time frame: Up to 24 hours after surgery.
Time to discharge
Time frame: Trough hospital stay, an average of 1 week.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Background: PubMed 31256367Belcaid I, Eipe N. Perioperative Pain Management in Morbid Obesity. Drugs. 2019 Jul;79(11):1163-1175. doi: 10.1007/s40265-019-01156-3.
- Background: PubMed 16517328Feld JM, Hoffman WE, Stechert MM, Hoffman IW, Ananda RC. Fentanyl or dexmedetomidine combined with desflurane for bariatric surgery. J Clin Anesth. 2006 Feb;18(1):24-8. doi: 10.1016/j.jclinane.2005.05.009.
- Background: PubMed 21773855Laskowski K, Stirling A, McKay WP, Lim HJ. A systematic review of intravenous ketamine for postoperative analgesia. Can J Anaesth. 2011 Oct;58(10):911-23. doi: 10.1007/s12630-011-9560-0. Epub 2011 Jul 20.
- Background: PubMed 30474791Ciftci B, Ekinci M, Celik EC, Kaciroglu A, Karakaya MA, Demiraran Y, Ozdenkaya Y. Comparison of Intravenous Ibuprofen and Paracetamol for Postoperative Pain Management after Laparoscopic Sleeve Gastrectomy. A Randomized Controlled Study. Obes Surg. 2019 Mar;29(3):765-770. doi: 10.1007/s11695-018-3613-1.
- Background: PubMed 28120147Bamgbade OA, Oluwole O, Khaw RR. Perioperative Analgesia for Fast-Track Laparoscopic Bariatric Surgery. Obes Surg. 2017 Jul;27(7):1828-1834. doi: 10.1007/s11695-017-2562-4.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ersin Koksal principal investigator
Ondokuz Mayıs University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocain, Ketamine and Dexmedetomidine in people with Morbid Obesity and Bariatric Surgery Candidate, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
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 10 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: finished, as of the sponsor's last update on 2 Jul 2021. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative pain: VAS scores at rest and movement (time frame: Up to 15 days after the surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04836819, which also lists 5 linked publications.
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 2 Jul 2021.