ObesityNCT04525274
Intraperitoneal Dexmedetomidine Versus Ketamine With Bupivacaine For Postoperative Analgesia
A study testing normal saline, dexmedetomidine and Ketamine in people with Obesity, run by Zagazig University at 1 site in Egypt.
Trial summary
Post-laparoscopic sleeve pain management is essential for early mobilization of the patient and so on decrease post-operative complication. The use of opioids is associated with adverse effects such as nausea, pruritus, sedation, and occasionally respiratory depression. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- normal saline, dexmedetomidine and Ketamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 20 May 2022
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient acceptance.
- Age 21-60 years old.
- Sex both male and female.
- BMI ≥40 kg/m2
- ASA II and ASA III.
- Scheduled for elective laparoscopic sleeve gastrectomy under general anesthesia.
Who cannot join
- Patients with known history of allergy to study drugs.
- Patients with uncontrolled diabetes mellitus.
- Psychological and mental disorders.
- Severe hypertensive, cardiac, hepatic and renal patients.
- Patients on opioid or sedative use.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Intraperitoneal Dexmedetomidine Versus Ketamine With Bupivacaine For Postoperative Analgesia After Laparoscopic Sleeve Gastrectomy
Post-laparoscopic sleeve pain management is essential for early mobilization of the patient and so on decrease post-operative complication. The use of opioids is associated with adverse effects such as nausea, pruritus, sedation, and occasionally respiratory depression.
Previous studies stated that intraperitoneal instillation of bupivacaine alone has been used to reduce acute postoperative abdominal and shoulder pain allow early mobilization and decrease postoperative opioid requirements and its complications.
In this study the investigators will compare between intraperitoneal instillation of dexmedetomidine with bupivacaine versus ketamine with bupivacaine in patients undergoing laparoscopic sleeve gastrectomy under general anesthesia regarding to postoperative pain relief to reduce morbidity and mortality.
Read the detailed description
Obesity is a serious condition in developed and developing countries occur due to some hormonal disorder or due to reduce energy expenditure with increasing energy uptake [1]. Nowadays, obesity considered the second cause of deaths after smoking all over the world [2].
Severe obesity increase the incidence of many chronic disease such as (diabetes mellitus, hypertension, cardiovascular diseases and others) [3]. This leads to substantial morbidity, early mortality [4], impaired quality of life [5] and excess healthcare expenditures [6].
Laparoscopic bariatric surgery is the most recommended and effective long-term treatment for morbid obesity (which body mass index (BMI) ≥40 kg/m2) and obesity-related complication [7].
Postoperative pain management after laparoscopic sleeve still considers a major challenge. As many of the patients express moderate-to-severe pain in postoperative period [8]. Causes of postoperative pain include inflammation of the peritoneum, intra-abdominal cavity stretch and irritation of diaphragm by carbon-dioxide (CO2) remains in the abdominal cavity [9].
Multimodal analgesia regimens such as parenteral opioids, nonsteroidal anti-inflammatory drugs and intraperitoneal instillation of different drugs such as local anesthetic drugs alone or with adjuvants like; opioid and α2 agonists' drugs such as clonidine and dexmedetomidine have been tried to reduce overall pain and postoperative complications of patients undergoing laparoscopic surgeries [8, 9].
Bupivacaine is the most commonly used local anesthetic drug, its intraperitoneal instillation has become a popular practice for pain relief after laparoscopic surgery as it causes blockade of free afferent nerve endings in peritoneum [10].
Dexmedetomidine, the pharmacologically active d-isomer of medetomidine, it is a potent and highly selective α2-adrenoreceptor agonist with sympatholytic, sedative, amnestic, anxiolytic, neuroprotective and analgesic properties [11].
Ketamine is an immunomodulatory agent and anti-inflammatory drug and it has a noncompetitive antagonist of the N-methyl-d-aspartate (NMDA) receptor that blocks nociceptive input and reduce hyperalgesia [12].
- Conditions
- Obesity
- Being tested
- normal saline, dexmedetomidine, Ketamine
- Keywords
- sleeve gastrectomy, postoperative analgesia, intraperitoneal dexmedetomidine, intraperitoneal ketamine
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal salineDrug
At the end of surgery, patient will be shifted to Trendelenburg position and intraperitoneal instillation of 40 ml bupivacaine 0.25% + 5 ml normal saline will be done guided by the camera and sprayed uniformly into the peritoneal cavity by the surgeon.
The patient will be maintained in Trendelenburg position for 5-10 minutes after drug instillation and the abdomen will be deflated by passive exsufflation using gentle abdominal pressure.
dexmedetomidineDrug
At the end of surgery, patient will be shifted to Trendelenburg position and intraperitoneal instillation of the study drug(40 ml bupivacaine 0.25% + 1 µg/kg dexmedetomidine diluted in 5 ml normal saline) will be done guided by the camera and sprayed uniformly into the peritoneal cavity by the surgeon.
The patient will be maintained in Trendelenburg position for 5-10 minutes after drug instillation and the abdomen will be deflated by passive exsufflation using gentle abdominal pressure.
KetamineDrug
At the end of surgery, patient will be shifted to Trendelenburg position and intraperitoneal instillation of the study drug(40 ml bupivacaine 0.25% + 0.5 mg/kg ketamine diluted in 5 ml normal saline) will be done guided by the camera and sprayed uniformly into the peritoneal cavity by the surgeon.
The patient will be maintained in Trendelenburg position for 5-10 minutes after drug instillation and the abdomen will be deflated by passive exsufflation using gentle abdominal pressure.
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | patient will receive 40 ml bupivacaine 0.25% + 5 ml normal saline with a total volume of 45 ml to be installed intraperitoneally. Receives: Drug: normal saline |
| dexmedetomidine group | Active comparator | patient will receive 40 ml bupivacaine 0.25% + 1 µg/kg dexmedetomidine diluted in 5 ml normal saline with a total volume of 45 ml to be installed intraperitoneally. Receives: Drug: dexmedetomidine |
| ketamine group | Active comparator | patient will receive 40 ml bupivacaine 0.25% + 0.5 mg/kg ketamine diluted in 5 ml normal saline with a total volume of 45 ml to be installed intraperitoneally. Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in assessment of postoperative shoulder, abdominal and incisional pain
will be assessed by visual analogue scale (VAS) scale, On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain.
Measured: at 1, 2, 4, 6, 12 and 24 hours postoperatively
Secondary outcomes (3)
Time of first request of analgesia
time elapsed from patient arrival to PACU [T0] to time of first patient call for analgesia
Measured: within 24 hour postoperative
Total rescue analgesic requirement
if VAS ≥3 or on patient request, rescue analgesia will be given
Measured: during the first postoperative 24 hours
The incidence of postoperative nausea and vomiting (PONV)
occurrence of postoperative nausea and vomiting
Measured: during the first postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start1 Oct 2021
- Primary completion30 Apr 2022
- Study completion20 May 2022
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 ObesityStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- The patients will be divided randomly by a computer-generated randomization table into three equal groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Rehab Abd-Allah Wahdan, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525274
- Sponsor's protocol ID
- 20-7-2020
- Status last verified
- Apr 2023
- First submitted
- 16 Aug 2020
- Last updated
- 27 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: planned after the completion of the study and publication
Publications
Ozkan AS. Anesthesia management in sleeve gastrectomy: Single center experience. Annals of Medical Research. 2018; 25(4)613-8.
Tekeli AE, Eker E, Bartin MK, Oner MO. Anesthesia Management in Laparoscopic Sleeve Gastrectomy Cases. East J Med. 2019; 24(3): 335-9.
Praveena BL, Bharathi B, Sahana VR. Intraperitoneal Ropivacaine with Dexmedetomidine or Fentanyl for Postoperative Analgesia Following Laparoscopic Cholecystectomy: A Comparative Randomized Trial. Anesth Essays Res. 2019 Jan-Mar;13(1):169-173. doi: 10.4103/aer.AER_191_18.
PubMed 31031500Beder El Baz MM, Farahat TEM. Intraperitoneal Levobupivacaine Alone or with Dexmedetomidine for Postoperative Analgesia after Laparoscopic Cholecystectomy. Anesth Essays Res. 2018 Apr-Jun;12(2):355-358. doi: 10.4103/aer.AER_205_17.
PubMed 29962597EL-Gaby SS, Mohammed SS. Intraperitoneal ketamine attenuates the inflammatory reactivity associated with pneumoperitoneum. Research and Opinion in Anesthesia & Intensive Care. 2017; 4:149-55.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Intraperitoneal Dexmedetomidine Versus Ketamine With Bupivacaine For Postoperative Analgesia After Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT04525274
- Acronym / sponsor ID
- 20-7-2020
- Conditions
- Obesity
- Keywords
- sleeve gastrectomy, postoperative analgesia, intraperitoneal dexmedetomidine, intraperitoneal ketamine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 25 Aug 2020 (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.
Post-laparoscopic sleeve pain management is essential for early mobilization of the patient and so on decrease post-operative complication. The use of opioids is associated with adverse effects such as nausea, pruritus, sedation, and occasionally respiratory depression.
Previous studies stated that intraperitoneal instillation of bupivacaine alone has been used to reduce acute postoperative abdominal and shoulder pain allow early mobilization and decrease postoperative opioid requirements and its complications.
In this study the investigators will compare between intraperitoneal instillation of dexmedetomidine with bupivacaine versus ketamine with bupivacaine in patients undergoing laparoscopic sleeve gastrectomy under general anesthesia regarding to postoperative pain relief to reduce morbidity and mortality.
Detailed description
Obesity is a serious condition in developed and developing countries occur due to some hormonal disorder or due to reduce energy expenditure with increasing energy uptake [1]. Nowadays, obesity considered the second cause of deaths after smoking all over the world [2].
Severe obesity increase the incidence of many chronic disease such as (diabetes mellitus, hypertension, cardiovascular diseases and others) [3]. This leads to substantial morbidity, early mortality [4], impaired quality of life [5] and excess healthcare expenditures [6].
Laparoscopic bariatric surgery is the most recommended and effective long-term treatment for morbid obesity (which body mass index (BMI) ≥40 kg/m2) and obesity-related complication [7].
Postoperative pain management after laparoscopic sleeve still considers a major challenge. As many of the patients express moderate-to-severe pain in postoperative period [8]. Causes of postoperative pain include inflammation of the peritoneum, intra-abdominal cavity stretch and irritation of diaphragm by carbon-dioxide (CO2) remains in the abdominal cavity [9].
Multimodal analgesia regimens such as parenteral opioids, nonsteroidal anti-inflammatory drugs and intraperitoneal instillation of different drugs such as local anesthetic drugs alone or with adjuvants like; opioid and α2 agonists' drugs such as clonidine and dexmedetomidine have been tried to reduce overall pain and postoperative complications of patients undergoing laparoscopic surgeries [8, 9].
Bupivacaine is the most commonly used local anesthetic drug, its intraperitoneal instillation has become a popular practice for pain relief after laparoscopic surgery as it causes blockade of free afferent nerve endings in peritoneum [10].
Dexmedetomidine, the pharmacologically active d-isomer of medetomidine, it is a potent and highly selective α2-adrenoreceptor agonist with sympatholytic, sedative, amnestic, anxiolytic, neuroprotective and analgesic properties [11].
Ketamine is an immunomodulatory agent and anti-inflammatory drug and it has a noncompetitive antagonist of the N-methyl-d-aspartate (NMDA) receptor that blocks nociceptive input and reduce hyperalgesia [12].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- The patients will be divided randomly by a computer-generated randomization table into three equal groups
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Drug: normal salinepatient will receive 40 ml bupivacaine 0.25% + 5 ml normal saline with a total volume of 45 ml to be installed intraperitoneally. |
| dexmedetomidine group | Active comparator | Drug: dexmedetomidinepatient will receive 40 ml bupivacaine 0.25% + 1 µg/kg dexmedetomidine diluted in 5 ml normal saline with a total volume of 45 ml to be installed intraperitoneally. |
| ketamine group | Active comparator | Drug: Ketaminepatient will receive 40 ml bupivacaine 0.25% + 0.5 mg/kg ketamine diluted in 5 ml normal saline with a total volume of 45 ml to be installed intraperitoneally. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patient acceptance.
- Age 21-60 years old.
- Sex both male and female.
- BMI ≥40 kg/m2
- ASA II and ASA III.
Key exclusion criteria (5 listed)
- Patients with known history of allergy to study drugs.
- Patients with uncontrolled diabetes mellitus.
- Psychological and mental disorders.
- Severe hypertensive, cardiac, hepatic and renal patients.
- Patients on opioid or sedative use.
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 |
|---|---|---|
| normal salineAt the end of surgery, patient will be shifted to Trendelenburg position and intraperitoneal instillation of 40 ml bupivacaine 0.25% + 5 ml normal saline will be done guided by the camera and sprayed uniformly into the peritoneal cavity by the surgeon. The patient will be maintained in Trendelenburg position for 5-10 minutes after drug instillation and the abdomen will be deflated by passive exsufflation using gentle abdominal pressure. | Drug | control group |
| dexmedetomidineAt the end of surgery, patient will be shifted to Trendelenburg position and intraperitoneal instillation of the study drug(40 ml bupivacaine 0.25% + 1 µg/kg dexmedetomidine diluted in 5 ml normal saline) will be done guided by the camera and sprayed uniformly into the peritoneal cavity by the surgeon. The patient will be maintained in Trendelenburg position for 5-10 minutes after drug instillation and the abdomen will be deflated by passive exsufflation using gentle abdominal pressure. | Drug | dexmedetomidine group |
| KetamineAt the end of surgery, patient will be shifted to Trendelenburg position and intraperitoneal instillation of the study drug(40 ml bupivacaine 0.25% + 0.5 mg/kg ketamine diluted in 5 ml normal saline) will be done guided by the camera and sprayed uniformly into the peritoneal cavity by the surgeon. The patient will be maintained in Trendelenburg position for 5-10 minutes after drug instillation and the abdomen will be deflated by passive exsufflation using gentle abdominal pressure. | Drug | ketamine group |
Primary outcome
change in assessment of postoperative shoulder, abdominal and incisional pain
Time frame: at 1, 2, 4, 6, 12 and 24 hours postoperatively
will be assessed by visual analogue scale (VAS) scale, On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain.
3 secondary outcomes
Time of first request of analgesia
Time frame: within 24 hour postoperative
Total rescue analgesic requirement
Time frame: during the first postoperative 24 hours
The incidence of postoperative nausea and vomiting (PONV)
Time frame: during the first postoperative 24 hours
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 27 Apr 2023.
- Results publicationOzkan AS. Anesthesia management in sleeve gastrectomy: Single center experience. Annals of Medical Research. 2018; 25(4)613-8.
- Results publicationTekeli AE, Eker E, Bartin MK, Oner MO. Anesthesia Management in Laparoscopic Sleeve Gastrectomy Cases. East J Med. 2019; 24(3): 335-9.
- Results publication: PubMed 31031500Praveena BL, Bharathi B, Sahana VR. Intraperitoneal Ropivacaine with Dexmedetomidine or Fentanyl for Postoperative Analgesia Following Laparoscopic Cholecystectomy: A Comparative Randomized Trial. Anesth Essays Res. 2019 Jan-Mar;13(1):169-173. doi: 10.4103/aer.AER_191_18.
- Results publication: PubMed 29962597Beder El Baz MM, Farahat TEM. Intraperitoneal Levobupivacaine Alone or with Dexmedetomidine for Postoperative Analgesia after Laparoscopic Cholecystectomy. Anesth Essays Res. 2018 Apr-Jun;12(2):355-358. doi: 10.4103/aer.AER_205_17.
- Results publicationEL-Gaby SS, Mohammed SS. Intraperitoneal ketamine attenuates the inflammatory reactivity associated with pneumoperitoneum. Research and Opinion in Anesthesia & Intensive Care. 2017; 4:149-55.
- Individual participant dataSharing planned: Yes. planned after the completion of the study and publication
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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.
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 normal saline, dexmedetomidine and Ketamine in people with Obesity, run by Zagazig 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 6 inclusion and 5 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 27 Apr 2023. 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. 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?
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?
change in assessment of postoperative shoulder, abdominal and incisional pain (time frame: at 1, 2, 4, 6, 12 and 24 hours postoperatively). 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 NCT04525274, 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 27 Apr 2023.