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Prophylaxis Against Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

Primary Purpose

Postoperative Nausea and Vomiting, Laparoscopic Cholecystectomy

Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline .
Ondansetron 4mg + dexamethasone 8mg + normal saline.
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Nausea and Vomiting focused on measuring dexamethasone, dexmedetomidine, ondansetron

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Tanta University hospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Dexmedetomidine Group

Dexamethasone Group

Arm Description

will receive ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline to complete 10 ml. volume IV infusion over 10 minutes.

will receive Ondansetron 4mg + dexamethasone 8mg + normal saline to complete 10 ml. volume IV infusion over 10 minutes.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
- Postoperative pain
Pain score was also assessed using a 10-point NRS.
- 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.

Full Information

First Posted
August 14, 2023
Last Updated
August 26, 2023
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT06017167
Brief Title
Prophylaxis Against Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
Official Title
Dexmedetomidine Versus Dexamethasone Adding to Ondansetron for Prophylaxis Against Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting, Laparoscopic Cholecystectomy
Keywords
dexamethasone, dexmedetomidine, ondansetron

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomly classified with computer generated random numbers into two equal groups (each group 35 patients) Group I: will receive Ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline to complete 10 ml. volume IV infusion over 10 minutes. Group II: will receive Ondansetron 4mg + dexamethasone 8mg + normal saline to complete 10 ml volume IV ifusion over 10 minutes.
Masking
ParticipantOutcomes Assessor
Masking Description
Double (Participant, Outcomes Assessor) 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.
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine Group
Arm Type
Active Comparator
Arm Description
will receive ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline to complete 10 ml. volume IV infusion over 10 minutes.
Arm Title
Dexamethasone Group
Arm Type
Active Comparator
Arm Description
will receive Ondansetron 4mg + dexamethasone 8mg + normal saline to complete 10 ml. volume IV infusion over 10 minutes.
Intervention Type
Drug
Intervention Name(s)
Ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline .
Other Intervention Name(s)
ondansetron 4mg (Zofran; GlaxoSmithKline, Alexandria, USA, dexmedetomidine (Precedex; Ho-Spira Inc., Lake Forest, Illinois, USA
Intervention Description
compare antiemetic effects between dexmedetomidine and ondansetron in the first group versus dexamethasone and ondansetron in the second group
Intervention Type
Drug
Intervention Name(s)
Ondansetron 4mg + dexamethasone 8mg + normal saline.
Other Intervention Name(s)
ondansetron 4mg (Zofran; GlaxoSmithKline, Alexandria, USA, dexamethasone; Amriya Pharmaceutical Industries, Egypt
Intervention Description
Group II: Ondansetron 4mg + dexamethasone 8mg + normal saline.
Primary Outcome Measure Information:
Title
The incidence of postoperative nausea and vomiting after laparoscopic cholecystectomy.
Description
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.
Time Frame
through out 24 hours after surgery.
Secondary Outcome Measure Information:
Title
The severity of post operative nausea and vomiting.
Description
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.
Time Frame
During 24 hours after surgery.
Title
- Postoperative pain
Description
Pain score was also assessed using a 10-point NRS.
Time Frame
During 24 hours after surgery.
Title
- Postoperative sedation
Description
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.
Time Frame
During 24 hours after surgery.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
According to APFEL score female is a risk factor for PONV.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yasmine M. Eldeba, BA
Phone
0021097732321
Email
yasmine162078_pg@med.tanta.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Rehab S. Elkalla, PHD
Phone
01285700765
Email
rehab.mohamed@med.tanta.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed A. Lotfy, PHD
Organizational Affiliation
Assistant Professor of Anesthesia and Intensive Care, Tanta Univ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tanta University hospitals
City
Tanta
State/Province
Algharbia
ZIP/Postal Code
31511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sohair Soliman, professor
Phone
00201283929049
Email
sohairsoliman@hotmail.com
First Name & Middle Initial & Last Name & Degree
Rehab Elkalla, M.D
Phone
01285700765
Email
rehab.mohamed@med.tanta.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
10382187
Citation
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.
Results Reference
background

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Prophylaxis Against Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

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