Prophylaxis Against Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

August 26, 2023 updated by: yasmine mohammed mahmoud mustafa eldeba, Tanta University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dexmedetomidine Group
will receive ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline to complete 10 ml. volume IV infusion over 10 minutes.
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
Other Names:
  • ondansetron 4mg (Zofran; GlaxoSmithKline, Alexandria, USA
  • dexmedetomidine (Precedex; Ho-Spira Inc., Lake Forest, Illinois, USA
Active Comparator: Dexamethasone Group
will receive Ondansetron 4mg + dexamethasone 8mg + normal saline to complete 10 ml. volume IV infusion over 10 minutes.
Drug: Ondansetron 4mg + dexamethasone 8mg + normal saline.
Group II: Ondansetron 4mg + dexamethasone 8mg + normal saline.
Other Names:
  • ondansetron 4mg (Zofran; GlaxoSmithKline, Alexandria, USA
  • dexamethasone; Amriya Pharmaceutical Industries, Egypt

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of postoperative nausea and vomiting after laparoscopic cholecystectomy.
Time Frame: through out 24 hours after surgery.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The severity of post operative nausea and vomiting.
Time Frame: During 24 hours after surgery.

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.
- Postoperative pain
Time Frame: During 24 hours after surgery.
Pain score was also assessed using a 10-point NRS.
During 24 hours after surgery.
- Postoperative sedation
Time Frame: During 24 hours after surgery.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: Mohamed A. Lotfy, PHD, Assistant Professor of Anesthesia and Intensive Care, Tanta Univ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2022

Primary Completion (Estimated)

September 1, 2023

Study Completion (Estimated)

October 1, 2023

Study Registration Dates

First Submitted

August 14, 2023

First Submitted That Met QC Criteria

August 26, 2023

First Posted (Actual)

August 30, 2023

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 26, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PONV after lap cholecystectomy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The IPD will be available with the principle investigator within 6 months after publishing the study

IPD Sharing Time Frame

within 6 months after publishing the study

IPD Sharing Access Criteria

yasmine162078_pg@med.tanta.edu.eg

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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