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.
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
- Recruiting
Kasralaini Medical School
Cairo
BESHOY ATEF, Msc, 01220703346, beshoyatef01@gmail.com
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.
- Conditions
- Nausea and Vomiting, Postoperative
- Being tested
- Dexmedetomidine, Propofol
- 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 group | Role | What they receive |
|---|---|---|
| Propofol group | Experimental | will receive propofol infusion. Receives: Drug: Propofol |
| Dexmedetomidine group | Experimental | will receive dexmedetomidine infusion. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary outcome
Number of PONV episodes in patients undergoing ureteroscopic procedures under spinal anesthesia
Measured: 6 hours
Secondary outcomes (2)
secondry outcome
heart rate
Measured: 2 hours
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.
- First posted25 May 2023
- Study start1 May 2022
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nausea and Vomiting, PostoperativeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beshoy Atef Nagiub, Cairo University
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Propofol Versus Dexmedetomidine on the Incidence of Postoperative Nausea and Vomiting in Ureteroscopic Procedures Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT05875077
- Acronym / sponsor ID
- MD-62-2022
- Conditions
- Nausea and Vomiting, Postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol group | Experimental | Drug: Propofolwill receive propofol infusion. |
| Dexmedetomidine group | Experimental | Drug: Dexmedetomidinewill receive dexmedetomidine infusion. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidinecompare 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. | Drug | Dexmedetomidine group |
| Propofolcompare 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. | Drug | Propofol group |
Primary outcome
primary outcome
Time frame: 6 hours
Number of PONV episodes in patients undergoing ureteroscopic procedures under spinal anesthesia
2 secondary outcomes
secondry outcome
Time frame: 2 hours
tertiary outcome
Time frame: 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Background: PubMed 22290456Myles 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.