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Nausea and Vomiting, PostoperativeNCT05875077

Propofol Versus Dexmedetomidine on the Incidence of Postoperative Nausea and Vomiting

A study testing Dexmedetomidine and Propofol in people with Nausea and Vomiting, Postoperative, run by Cairo University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Nausea and Vomiting, Postoperative
What is being tested?
Dexmedetomidine and Propofol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteEgypt
Study dates
1 May 2022to 1 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site, 1 recruiting
  • Kasralaini Medical School

    Cairo

    BESHOY ATEF, Msc, 01220703346, beshoyatef01@gmail.com

    Recruiting

Other trials in Egypt

About this study

Official title: The Effect of Propofol Versus Dexmedetomidine on the Incidence of Postoperative Nausea and Vomiting in Ureteroscopic Procedures Under Spinal Anesthesia

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).

Read the 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.

Medical subject headings
Postoperative Nausea and Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexmedetomidineDrug

    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.

  • PropofolDrug

    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.

Study groups in NCT05875077
Study groupRoleWhat they receive
Propofol groupExperimentalwill receive propofol infusion.
Receives: Drug: Propofol
Dexmedetomidine groupExperimentalwill receive dexmedetomidine infusion.
Receives: Drug: Dexmedetomidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. primary outcome

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

    Measured: 6 hours

Secondary outcomes (2)
  1. secondry outcome

    heart rate

    Measured: 2 hours

  2. tertiary outcome

    arterial blood pressure

    Measured: 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2023
  2. Study start1 May 2022
  3. Primary completion1 Jan 2024 (estimated)
  4. Study completion1 Feb 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05875077
Sponsor's protocol ID
MD-62-2022
Status last verified
Aug 2023
First submitted
3 Apr 2023
Last updated
31 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22290456

Questions about this trial

What is this clinical trial studying?

A study testing Dexmedetomidine and Propofol in people with Nausea and Vomiting, Postoperative, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact BESHOY ATEF (01220703346, beshoyatef01@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

primary outcome (time frame: 6 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05875077, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.

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