Prophylaxis Against Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

Postoperative Nausea and Vomiting Clinical Trial

Official title:

Dexmedetomidine Versus Dexamethasone Adding to Ondansetron for Prophylaxis Against Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06017167
• Other study ID #: PONV after lap cholecystectomy
• Status: Recruiting
• Phase: Phase 2
• Start date: September 15, 2022
• Est. completion date: October 2023

Study information

• Verified date: August 2023
• Source: Tanta University
• Contact: Yasmine M. Eldeba, BA
• Phone: 0021097732321
• Email: yasmine162078_pg[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to compare antiemetic effects between dexmedetomidine and ondansteron in the first group versus dexamethasone and ondansteron in the second group.

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.

Description:

General anesthesia is widely used in several surgeries. It can cause some complications such as postoperative nausea and vomiting (PONV). PONV is more common in general anesthesia than spinal anesthesia. PONV remains an extremely significant challenge due to its complex mechanism, resulting in serious consequences. Therefore an effective way to prevent or arrest PONV is urgently needed as Also, it can cause electrolyte imbalance and aggravate bleeding that delay hospital discharge.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: October 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 70 Female patients aged between 18 and 65 years

• ASA I or II

• patients scheduled for elective laparoscopic cholecystectomy surgery will be included in this study.

Exclusion Criteria:

• Females above 65 years old.

• 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.

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy
• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Egypt	Tanta University hospitals	Tanta	Algharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of postoperative nausea and vomiting after laparoscopic cholecystectomy.	The incidence of vomiting, use of rescue antiemetics, and analgesic requirements were recorded at 0 to 1 hours after surgery in the postanesthetic care unit (PACU)At 6 and 24 hours after surgery, the incidence and severity of PONV were assessed using the Rhodes Index of nausea, vomiting, and retching.	through out 24 hours after surgery.
Secondary	The severity of post operative nausea and vomiting.	The severity of nausea was evaluated using a 10-point numerical rating scale (NRS) At 6 and 24 hours after surgery, the incidence and severity of PONV were assessed using the Rhodes Index of nausea, vomiting, and reteching.At 6 and 24 hours after surgery.; The Rhodes Index is a reliable and valid patient self-reporting tool to assess nausea, vomiting, and retching and consists of eight items with 5 scales (0-4). This index has been shown to be a highly reliable method for evaluating gastrointestinal distress after ambulatory surgery.	During 24 hours after surgery.
Secondary	- Postoperative pain	Pain score was also assessed using a 10-point NRS.	During 24 hours after surgery.
Secondary	- Postoperative sedation	Ramsay sedation score (1=agitated, anxious, or restless; 2=oriented, cooperated, and tranquil; 3=responsive to verbal commands only; 4=asleep, brisk response to a loud auditory stimulus or a light glabella tap; 5=sluggish response to a glabella tap or loud auditory stimulus; 6=no response to a loud auditory stimulus or a light glabella tap) were recorded. Over-sedation was defined as a Ramsay sedation score>4.	During 24 hours after surgery.