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Propofol Versus Dexmedetomidine on the Incidence of Postoperative Nausea and Vomiting

Primary Purpose

Nausea and Vomiting, Postoperative

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine
Propofol
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nausea and Vomiting, Postoperative

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients aged 18 to 60 years ASA physical status I-II Scheduled for ureteroscopic procedure With more than one Risk factor for PONV (female, history of PONV, non-smoking). Exclusion Criteria: Patients with contraindications for spinal anesthesia including infection at the injection site, bleeding diathesis, known left ventricular outflow obstruction, hypovolemia, and increased intracranial pressure. History of allergy or hypersensitivity to propofol or dexmedetomidine. Gastrointestinal diseases e.g. gastroenteritis and gastric ulcers, ear diseases e.g. infections of middle and inner ear, liver cirrhosis. Those who have received antiemetic drugs within 48 hours before surgery. Operations lasting more than two hours. The patient's unwillingness.

Sites / Locations

  • Kasralaini Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Propofol group

Dexmedetomidine group

Arm Description

will receive propofol infusion.

will receive dexmedetomidine infusion.

Outcomes

Primary Outcome Measures

primary outcome
Number of PONV episodes in patients undergoing ureteroscopic procedures under spinal anesthesia

Secondary Outcome Measures

secondry outcome
heart rate
tertiary outcome
arterial blood pressure

Full Information

First Posted
April 3, 2023
Last Updated
August 30, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05875077
Brief Title
Propofol Versus Dexmedetomidine on the Incidence of Postoperative Nausea and Vomiting
Official Title
The Effect of Propofol Versus Dexmedetomidine on the Incidence of Postoperative Nausea and Vomiting in Ureteroscopic Procedures Under Spinal Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Post-operative nausea and vomiting are a leading cause of recovery room delays and low patient satisfaction. Complications such as suture line tension, wound hemorrhage and dehiscence, elevated intracranial pressure, pulmonary aspiration, dehydration, and electrolyte imbalance have been linked to nausea and vomiting. Many studies were done to explore the effects of propofol and dexmedetomidine on the incidence of post operative nausea and vomiting (PONV). In this study, we will compare propofol infusion to dexmedetomidine infusion on the incidence of PONV in patients undergoing ureteroscopic procedures under spinal anesthesia in the age group from 18 to 60 years with more than one risk factor for PONV (female, history of PONV, non-smoking).
Detailed Description
In regional anesthesia, the mechanism of postoperative nausea and vomiting through the effect of hypotension is extremely common. Low blood pressure can cause ischemia in the brain stem, which activates the medulla's circulatory, respiratory, and vomiting centers. According to some researchers, hypotension causes gut ischemia and the release of emetogenic chemicals (such as serotonin) from the intestines. The function of the gastrointestinal tract is similarly altered by neuraxial anesthesia. Local anesthetics suppress the sympathetic nervous system, resulting in unopposed vagal action and gastrointestinal hyperactivity. The effectiveness of vagolytic drugs in relieving nausea during spinal anesthesia has been cited as proof of the mechanism's importance. During regional anesthesia, visceral discomfort is a powerful stimulator of emetic symptoms. Handling abdominal viscera stimulates sensory vagal fibers and activates the vomiting center, causing emesis. Although the specific mechanism by which propofol operates as an antiemetic is unknown, a central mechanism for propofol's antiemetic activity appears to be the most likely, and a peripheral antiemetic effect has also been considered. Because of its broad range of effects, which include anxiolytic, sedative, analgesic, anesthetic-sparing, sympatholytic, and hemodynamic-stabilizing qualities, dexmedetomidine is a powerful 2-adrenergic agonist with prospective applications in clinical anesthesia. The use of dexmedetomidine as an anesthetic adjuvant intraoperative has resulted in significant reductions in the use of opioids and inhalation anesthetics, as well as a decrease in the incidence of emergence agitation, a favorable recovery profile, and a decrease in postoperative pain without adverse hemodynamic effects. The aim of this study is to compare the effects of dexmedetomidine infusion to propofol infusion during spinal anesthesia, on the incidence of postoperative nausea and vomiting in patients undergoing ureteroscopic procedures under spinal anesthesia. Participants will be adults aged 18 to 60 years, scheduled for ureteroscopic procedures under spinal anesthesia. Included participants will be patients aged 18 to 60 years with American Society of Anesthesiologists physical status (ASA) I-II scheduled for a ureteroscopic procedure with more than one risk factor for PONV (female, history of PONV, non-smoking) during our study time frame. Excluded patients are those with contraindications to spinal anesthesia, including infection at the injection site, bleeding diathesis, known left ventricular outflow obstruction, hypovolemia, and increased intracranial pressure, history of allergy or hypersensitivity to propofol or dexmedetomidine, gastrointestinal diseases, e.g., gastroenteritis and gastric ulcers, ear diseases, e.g., infections of the middle and inner ear, liver cirrhosis, those who have received antiemetic drugs within 48 hours before surgery, those undergoing procedure taking more than two hours and patients unwilling to participate. After being accepted into the study, participants' age, gender, weight, medications, special habits (e.g., smoking history), history of PONV, and any other comorbidity will be collected. All subjects will be fasting for 6-8 hours for solids and at least 2 hours for clear fluids. Routine monitoring devices (five lead electrocardiograms, non-invasive blood pressure, and pulse oximetry) will be installed when the patient arrives in the operating room, and baseline mean blood pressure, heart rate, and oxygen saturation data will be collected. Before spinal anesthesia, each patient will be given 500 mL of Ringer solution. In the sitting posture, a 25-gauge spinal needle is used to puncture the L3-L4 interspace under sterile conditions and via the midline route. After the cerebrospinal fluid (CSF) free flow, 12.5-17.5 mg of bupivacaine will be given intrathecally, and patients will be placed in a supine posture and remain horizontal for at least 10 minutes. Patients will be randomly assigned to one of three groups (propofol, dexmedetomidine, or control) and will begin receiving an infusion of either propofol (at a rate of 1 mg/kg/hour), dexmedetomidine (at a rate of 0.5 micrograms/kg/hour with no boluses), or nothing in the control group. Patients will be given 3 liters of oxygen per minute through a nasal cannula after spinal anesthesia. After the sensory block at the level of T10 is confirmed by the lack of sensitivity to pinprick, surgery will begin. The heart rate, oxygen saturation, pulse rate, and mean arterial blood pressure will all be recorded. Mean arterial blood pressure readings will be taken before and after the spinal every 10 minutes till the end of the procedure. Hypotension is defined as a drop in mean arterial blood pressure (more than 20% below baseline) following spinal injection, and it is treated by increasing intravenous fluid administration and administering 2.5-5 milligram increments of ephedrine I.V. (every 3-5 minutes) until the hypotension is resolved. Intraoperatively and up to 6 hours after surgery, the frequency and severity of nausea and vomiting will be monitored using the PONV intensity scale. If the patient has had two or more bouts of nausea and vomiting, he will be given 10 mg of metoclopramide intravenously as a rescue antiemetic. Non steroidal anti inflammatory drugs (NSAIDS) will be used to provide analgesia post-surgery. The Ramsay sedation scale (RSS) will be used to assess the patient's level of sedation, with the sedation score being recorded right before the study medicines are injected and then every 10 minutes until the patient is discharged from the recovery room. The RSS scores are assigned from 1 to 6, with 1 indicating anxious, agitated, and restless behavior, 2 indicating sedation-oriented and tranquil behavior, 3 indicating sedation response to commands, 4 indicating a brisk response to light glabellar tap, 5 indicating a sluggish response to light glabellar tap, and 6 indicating deep sedation with no response.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea and Vomiting, Postoperative

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Propofol group
Arm Type
Experimental
Arm Description
will receive propofol infusion.
Arm Title
Dexmedetomidine group
Arm Type
Experimental
Arm Description
will receive dexmedetomidine infusion.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
compare the effects of dexmedetomidine infusion to propofol infusion during spinal anesthesia, on the incidence of postoperative nausea and vomiting in patients undergoing ureteroscopic procedures under spinal anesthesia.
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
compare the effects of dexmedetomidine infusion to propofol infusion during spinal anesthesia, on the incidence of postoperative nausea and vomiting in patients undergoing ureteroscopic procedures under spinal anesthesia.
Primary Outcome Measure Information:
Title
primary outcome
Description
Number of PONV episodes in patients undergoing ureteroscopic procedures under spinal anesthesia
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
secondry outcome
Description
heart rate
Time Frame
2 hours
Title
tertiary outcome
Description
arterial blood pressure
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients aged 18 to 60 years ASA physical status I-II Scheduled for ureteroscopic procedure With more than one Risk factor for PONV (female, history of PONV, non-smoking). Exclusion Criteria: Patients with contraindications for spinal anesthesia including infection at the injection site, bleeding diathesis, known left ventricular outflow obstruction, hypovolemia, and increased intracranial pressure. History of allergy or hypersensitivity to propofol or dexmedetomidine. Gastrointestinal diseases e.g. gastroenteritis and gastric ulcers, ear diseases e.g. infections of middle and inner ear, liver cirrhosis. Those who have received antiemetic drugs within 48 hours before surgery. Operations lasting more than two hours. The patient's unwillingness.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BESHOY ATEF
Phone
01220703346
Email
beshoyatef01@gmail.com
Facility Information:
Facility Name
Kasralaini Medical School
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BESHOY ATEF, Msc
Phone
01220703346
Email
beshoyatef01@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22290456
Citation
Myles PS, Wengritzky R. Simplified postoperative nausea and vomiting impact scale for audit and post-discharge review. Br J Anaesth. 2012 Mar;108(3):423-9. doi: 10.1093/bja/aer505. Epub 2012 Jan 29.
Results Reference
background

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Propofol Versus Dexmedetomidine on the Incidence of Postoperative Nausea and Vomiting

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