Intraperitoneal Dexmedetomidine Versus Ketamine With Bupivacaine For Postoperative Analgesia
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| ClinicalTrials.gov Identifier: NCT04525274 |
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Recruitment Status :
Recruiting
First Posted : August 25, 2020
Last Update Posted : August 24, 2021
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Obesity | Drug: normal saline Drug: dexmedetomidine Drug: Ketamine | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | The patients will be divided randomly by a computer-generated randomization table into three equal groups |
| Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
| Masking Description: | triple blinded (patient, surgeon and outcomes assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Comparative Study Between Intraperitoneal Dexmedetomidine Versus Ketamine With Bupivacaine For Postoperative Analgesia After Laparoscopic Sleeve Gastrectomy |
| Actual Study Start Date : | July 20, 2020 |
| Estimated Primary Completion Date : | September 20, 2021 |
| Estimated Study Completion Date : | October 20, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: control group
patient will receive 40 ml bupivacaine 0.25% + 5 ml normal saline with a total volume of 45 ml to be installed intraperitoneally.
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Drug: normal saline
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. |
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Active Comparator: dexmedetomidine group
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.
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Drug: dexmedetomidine
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. |
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Active Comparator: ketamine group
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.
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Drug: Ketamine
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. |
- 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.
- Time of first request of analgesia [ Time Frame: within 24 hour postoperative ]time elapsed from patient arrival to PACU [T0] to time of first patient call for analgesia
- Total rescue analgesic requirement [ Time Frame: during the first postoperative 24 hours ]if VAS ≥3 or on patient request, rescue analgesia will be given
- The incidence of postoperative nausea and vomiting (PONV) [ Time Frame: during the first postoperative 24 hours ]occurrence of postoperative nausea and vomiting
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| Ages Eligible for Study: | 21 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04525274
| Contact: Rehab A Wahdan, MD | 01003481323 ext 002 | obz13w@yahoo.com | |
| Contact: Asmaa M Galal, MD | 01271550089 ext 002 | asmaa_galal79@yahoo.com |
| Egypt | |
| faculty of medicine, Zagazig university | Recruiting |
| Zagazig, Elsharqya, Egypt, 44519 | |
| Contact: Howaida A Kamal, MD 01225096755 ext 002 k.howaida@yahoo.com | |
| Responsible Party: | Rehab Abd-Allah Wahdan, lecturer of anesthesia and surgical intensive care, Zagazig University |
| ClinicalTrials.gov Identifier: | NCT04525274 |
| Other Study ID Numbers: |
20-7-2020 |
| First Posted: | August 25, 2020 Key Record Dates |
| Last Update Posted: | August 24, 2021 |
| Last Verified: | August 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | planned after the completion of the study and publication |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Analytic Code |
| Time Frame: | planned after the completion of the study and publication |
| Access Criteria: | principal investigator |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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sleeve gastrectomy postoperative analgesia intraperitoneal dexmedetomidine intraperitoneal ketamine |
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Dexmedetomidine Ketamine Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists |
Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Anesthetics Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents |