Clinical trial NCT04525274: Intraperitoneal Dexmedetomidine Versus Ketamine With Bupivacaine For Postoperative Analgesia
Official title: Comparative Study Between Intraperitoneal Dexmedetomidine Versus Ketamine With Bupivacaine For Postoperative Analgesia After Laparoscopic Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: sleeve gastrectomy
postoperative analgesia
intraperitoneal dexmedetomidine
intraperitoneal ketamine
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-08-25
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients will be divided randomly by a computer-generated randomization table into three equal groups
Primary purpose: TREATMENT

Brief 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.

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 \[12\].

Eligibility criteria: 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.

Primary outcomes:
measure: change in assessment of postoperative shoulder, abdominal and incisional pain
timeFrame: at 1, 2, 4, 6, 12 and 24 hours postoperatively
Secondary outcomes:
measure: Time of first request of analgesia
timeFrame: within 24 hour postoperative
measure: Total rescue analgesic requirement
timeFrame: during the first postoperative 24 hours
measure: The incidence of postoperative nausea and vomiting (PONV)
timeFrame: during the first postoperative 24 hours
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: faculty of medicine, Zagazig university
state: Elsharqya
Study officials:
References:
citation: Ozkan AS. Anesthesia management in sleeve gastrectomy: Single center experience. Annals of Medical Research. 2018; 25(4)613-8.
citation: Tekeli AE, Eker E, Bartin MK, Oner MO. Anesthesia Management in Laparoscopic Sleeve Gastrectomy Cases. East J Med. 2019; 24(3): 335-9.
citation: 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.
citation: Beder 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.
citation: EL-Gaby SS, Mohammed SS. Intraperitoneal ketamine attenuates the inflammatory reactivity associated with pneumoperitoneum. Research and Opinion in Anesthesia & Intensive Care. 2017; 4:149-55.