Prophylaxis Against Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
NCT ID: NCT06017167
Last Updated: 2023-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
70 participants
INTERVENTIONAL
2022-09-15
2023-10-31
Brief Summary
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The primary outcome in this study is incidence of postoperative nausea and vomiting after laparoscopic cholecystectomy.
The secondary outcomes are:
* The severity of post operative nausea and vomiting.
* Use of rescue antiemetic drugs.
* Postoperative pain and sedation.
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Detailed Description
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The causes of PONV are multifactorial and can largely be categorized as patient risk factors, anaesthetic technique, and surgical procedure. Antiemetics work on several different receptor sites to prevent or treat PONV.
No single antiemetic pharmaceutical has been provided to be a universal solution to PONV. In general, multimodal combination treatment has superior viability for PONV prophylaxis compared with monotherapy .
Because nausea and vomiting were defined as two separate phe-nomena, studies should report and evaluate the variables distinctly . While since few patients experience vomiting without nausea, the incidence of PONV and postoperative nau¬sea (PON) is fairly similar, thus original papers often do not try to distinguish these variables . So, if PONV but not PON was reported in trails, we considered the PONV variables as a very close substitute for PON; when both PONV and PON were reported simultaneously, we assessed the nausea values. The most com¬monly used time interval to measure the role of antiemetic is 24 hours 6.
Ondansetron is a serotonin receptor antagonist, which is very important in preventing nausea and vomiting due to surgery and chemotherapy; it exhibited an anti-vomiting effect by inhibiting 5-Hydroxytryptamine type 3 (5-HT3) receptors in the vomiting centre .
Dexmedetomidine is a potent and highly selective a2-adrenoceptor agonist, which binds to transmembrane G protein-binding receptor located in the brain and spinal cord. Since nausea and vomit¬ing may be induced by high catecholamine con¬centrations, a decrease of sympathetic tone could explain the antiemetic effect of dexme¬detomidine. Finally, consumption of intraopera¬tive opioids, which increases the risk of PONV , may be reduced through the use of dexmedetomidine It affects the functions of central nervous, circulatory systems and exhibits sedative, analgesic, sympatholytic properties. Recently, the effect of dexmedetomidine on PONV has been the focus of clinical researchers. Nevertheless, controversy about the effectiveness of dexmedetomidine for PONV is still ongoing, for different results reported in associated literature.
Glucocorticoids may exert an antiemetic effect by inhibiting inflammatory mediators and by interacting with serotonin, neurokinin, a-adrenergic receptors, and other receptors. Furthermore, several studies have shown that dexamethasone enhances the antiemetic efficacies of 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Group II: will receive Ondansetron 4mg + dexamethasone 8mg + normal saline to complete 10 ml volume IV ifusion over 10 minutes.
TREATMENT
DOUBLE
* The participants will be kept blind in both groups.
* Outcome assessors will be blinded as they will be anesthesia resident and nurse not participating in the study.
Study Groups
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Dexmedetomidine Group
will receive ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline to complete 10 ml. volume IV infusion over 10 minutes.
Ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline .
compare antiemetic effects between dexmedetomidine and ondansetron in the first group versus dexamethasone and ondansetron in the second group
Dexamethasone Group
will receive Ondansetron 4mg + dexamethasone 8mg + normal saline to complete 10 ml. volume IV infusion over 10 minutes.
Ondansetron 4mg + dexamethasone 8mg + normal saline.
Group II: Ondansetron 4mg + dexamethasone 8mg + normal saline.
Interventions
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Ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline .
compare antiemetic effects between dexmedetomidine and ondansetron in the first group versus dexamethasone and ondansetron in the second group
Ondansetron 4mg + dexamethasone 8mg + normal saline.
Group II: Ondansetron 4mg + dexamethasone 8mg + normal saline.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ASA I or II
* patients scheduled for elective laparoscopic cholecystectomy surgery will be included in this study.
Exclusion Criteria
* patients under 18 years old.
* ASA \> II.
* Obesity (BMI\>40 kgm2).
* Known hypersensitivity to drugs used in the study protocol.
* Comorbidities that were known to increase the risk of PONV (e.g. vestibular disease).
* Liver or renal dysfunction (liver enzyme or creatinine 1.5 times higher than normal).
* Alcoholism or drug abuse.
* Use of antiemetics and psychotropic drugs or glucocorticoids within 24 h before surgery.
18 Years
65 Years
FEMALE
No
Sponsors
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Tanta University
OTHER
Responsible Party
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yasmine mohammed mahmoud mustafa eldeba
Resident doctor of Anaesthesia and ICU Department
Principal Investigators
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Mohamed A. Lotfy, PHD
Role: PRINCIPAL_INVESTIGATOR
Assistant Professor of Anesthesia and Intensive Care, Tanta Univ
Locations
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Tanta University hospitals
Tanta, Algharbia, Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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Rhodes VA, McDaniel RW. The Index of Nausea, Vomiting, and Retching: a new format of the lndex of Nausea and Vomiting. Oncol Nurs Forum. 1999 Jun;26(5):889-94.
Other Identifiers
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PONV after lap cholecystectomy
Identifier Type: -
Identifier Source: org_study_id
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