Postoperative Nausea and VomitingNCT05057767
Impact of Timing of Midazolam Administration on Incidence of Postoperative Nausea and Vomiting
A study testing Midazolam injection in people with Postoperative Nausea and Vomiting, run by Benha University at 1 site in Egypt.
Trial summary
Postoperative nausea and vomiting (PONV), defined as nausea and/or vomiting occurring within 24 hours after surgery, affects between 20% and 30% of patients, As many as 70% to 80% of patients at high risk may be affected. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Midazolam injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2021to 31 Jul 2022
- 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 20 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female patients
- aged twenty to sixty years old
- The American Society of Anesthesiologists (ASA) physical status classification grade I or II
- Scheduled for laparoscopic gynecological surgeries under general anesthesia.
Who cannot join
- Patients who have gastrointestinal disorders,
- histories of PONV after a previous surgery,
- Renal or liver dysfunction,
- history of motion sickness,
- Have received any opioid, steroid, or antiemetic medication in the 24hs before surgery, and
- Pregnant or menstruating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Timing of Midazolam Administration on Incidence of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gynecological Surgery; a Randomized Double-blinded Controlled Study
Postoperative nausea and vomiting (PONV), defined as nausea and/or vomiting occurring within 24 hours after surgery, affects between 20% and 30% of patients, As many as 70% to 80% of patients at high risk may be affected. The etiology of PONV is thought to be multifactorial, involving individual, anaesthetic and surgical risk factors. PONV results in increased patient discomfort and dissatisfaction and in increased costs related to length of hospital stay. Serious medical complications such as pulmonary aspiration, although uncommon, are also associated with vomiting.
Patients with a higher risk of PONV often require a combination or multimodal approach of 2 or more interventions for effective risk reduction. Thus, researchers have explored additional nontraditional antiemetics, such as midazolam, that would aid in the multimodal prevention of PONV.
Read the detailed description
Midazolam is often administered in the perioperative period to reduce anxiety in addition to causing sedation and amnesia. The pharmacologic qualities allow for a rapid onset, short duration, and short half-life. The clinical effects of midazolam result from an agonist action on the γ-aminobutyric acid A (GABAA) receptor throughout the central nervous system. Benzodiazepines do not work directly on the GABA receptor, so there is a physiologic ceiling effect, which contributes to their safety and low toxicity.
Although the exact antiemetic mechanisms remain unknown, researchers postulate that midazolam works on the chemoreceptor trigger zone by reducing the synthesis, release, and postsynaptic dopamine. It remains debatable whether midazolam reduces dopamine directly or blocks the reuptake of adenosine leading to an adenosine-mediated reduction of dopamine release. Additionally, the binding of midazolam to the GABA benzodiazepine complex may cause dopaminergic neuronal activity and the release of 5-hydroxytryptamine. The reduction of PONV may also be a secondary effect of the anxiolytic properties of benzodiazepines.
Despite literature demonstrating the PONV benefits of midazolam in the perioperative period, But the timing of administration of this drug is still not well established. As it is known that it has half-life of about 1.5 - 2.5 hours and the controversies remain whether to administer this drug preoperatively or postoperatively to prevent PONV. So this comparative study is designed to know the better time for administration of this drug to prevent PONV and to improve patient satisfaction.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Midazolam injection
- 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.
Midazolam injectionDrug
No premedication will be given to Patients in the group undergoing a standardized anesthesia protocol which include induction with thiopental (5 mg/kg) and fentanyl (1-2 μg/kg). Atracurium will be used as a muscle relaxant. After tracheal intubation, anesthesia will be maintained with isoflurane in a concentration of 0.8%-1.2%. Ventilation will be adjusted to produce normocapnia. At the end of surgery, reversal of residual neuromuscular blockade will be accomplished using i.v. atropine 20 μg/Kg and neostigmine 40 μg/kg.
| Study group | Role | What they receive |
|---|---|---|
| Pre-induction Group (I) | Experimental | will receive intravenous midazolam premedication 2mg in a volume of 3 ml, 15 minutes before induction of anesthesia Receives: Drug: Midazolam injection |
| Pre-extubation Group (II) | Experimental | will receive intravenous midazolam 2mg in a volume of 3 ml 30 minutes before extubation at the end of surgery Receives: Drug: Midazolam injection |
| Control Group (III) | Placebo comparator | will receive 3 ml normal saline 15 minutes before induction of anesthesia plus 3 ml normal saline 30 minutes before extubation at the end of surgery. Receives: Drug: Midazolam injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Operative Nausea Vomiting assessment
Nausea will be recorded according to the following scale: 0 none; 1 mild (patient able to eat); 2 moderate (oral intake significantly decreased); and 3 severe (no significant oral intake necessitating iv fluid). The absence of nausea will be defined as complete protection from nausea. An emetic episode will be defined as a single vomit or retch, or any number of continuous vomiting episodes or retches (one emetic episode should be separated from another by an absence of vomiting or retching for at least 1 min). The absence of emetic episodes will be defined as complete protection from vomiting.
Measured: 24 hours postoperative
Secondary outcomes (3)
requirements of rescue antiemetic
Rescue medication (metoclopramide 10 mg) will be given intravenously if patient is nauseous for more than 15 min or experiences retching or vomiting during the observation periods. The treatment will be repeated if necessary
Measured: 24 hours postoperative
Observer's Assessment of Alertness/ Sedation (OAA/S) scale
a six-point scale ranging from 5 to 0 that involves eliciting a response to increasingly intense stimuli that begin with speaking with a normal voice to prodding or shaking and finally to a painful stimulus (trapezius squeeze).
Measured: 120 minutes postoperative
Pain intensity score
measured with a visual analog scale (VAS) from 0 (no pain) to 10 (the worst possible pain).
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start10 Sep 2021
- Primary completion30 Jun 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Benha 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Rafik Mohamed Amin, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057767
- Sponsor's protocol ID
- RC-12-8-2021
- Status last verified
- Sep 2021
- First submitted
- 13 Sep 2021
- Last updated
- 16 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Timing of Midazolam Administration on Incidence of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gynecological Surgery; a Randomized Double-blinded Controlled Study
- ClinicalTrials.gov ID
- NCT05057767
- Acronym / sponsor ID
- RC-12-8-2021
- Conditions
- Postoperative Nausea and Vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 27 Sep 2021 (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.
Postoperative nausea and vomiting (PONV), defined as nausea and/or vomiting occurring within 24 hours after surgery, affects between 20% and 30% of patients, As many as 70% to 80% of patients at high risk may be affected. The etiology of PONV is thought to be multifactorial, involving individual, anaesthetic and surgical risk factors. PONV results in increased patient discomfort and dissatisfaction and in increased costs related to length of hospital stay. Serious medical complications such as pulmonary aspiration, although uncommon, are also associated with vomiting.
Patients with a higher risk of PONV often require a combination or multimodal approach of 2 or more interventions for effective risk reduction. Thus, researchers have explored additional nontraditional antiemetics, such as midazolam, that would aid in the multimodal prevention of PONV.
Detailed description
Midazolam is often administered in the perioperative period to reduce anxiety in addition to causing sedation and amnesia. The pharmacologic qualities allow for a rapid onset, short duration, and short half-life. The clinical effects of midazolam result from an agonist action on the γ-aminobutyric acid A (GABAA) receptor throughout the central nervous system. Benzodiazepines do not work directly on the GABA receptor, so there is a physiologic ceiling effect, which contributes to their safety and low toxicity.
Although the exact antiemetic mechanisms remain unknown, researchers postulate that midazolam works on the chemoreceptor trigger zone by reducing the synthesis, release, and postsynaptic dopamine. It remains debatable whether midazolam reduces dopamine directly or blocks the reuptake of adenosine leading to an adenosine-mediated reduction of dopamine release. Additionally, the binding of midazolam to the GABA benzodiazepine complex may cause dopaminergic neuronal activity and the release of 5-hydroxytryptamine. The reduction of PONV may also be a secondary effect of the anxiolytic properties of benzodiazepines.
Despite literature demonstrating the PONV benefits of midazolam in the perioperative period, But the timing of administration of this drug is still not well established. As it is known that it has half-life of about 1.5 - 2.5 hours and the controversies remain whether to administer this drug preoperatively or postoperatively to prevent PONV. So this comparative study is designed to know the better time for administration of this drug to prevent PONV and to improve patient satisfaction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre-induction Group (I) | Experimental | Drug: Midazolam injectionwill receive intravenous midazolam premedication 2mg in a volume of 3 ml, 15 minutes before induction of anesthesia |
| Pre-extubation Group (II) | Experimental | Drug: Midazolam injectionwill receive intravenous midazolam 2mg in a volume of 3 ml 30 minutes before extubation at the end of surgery |
| Control Group (III) | Placebo comparator | Drug: Midazolam injectionwill receive 3 ml normal saline 15 minutes before induction of anesthesia plus 3 ml normal saline 30 minutes before extubation at the end of surgery. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female patients
- aged twenty to sixty years old
- The American Society of Anesthesiologists (ASA) physical status classification grade I or II
- Scheduled for laparoscopic gynecological surgeries under general anesthesia.
Key exclusion criteria (6 listed)
- Patients who have gastrointestinal disorders,
- histories of PONV after a previous surgery,
- Renal or liver dysfunction,
- history of motion sickness,
- Have received any opioid, steroid, or antiemetic medication in the 24hs before surgery, and
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 |
|---|---|---|
| Midazolam injectionNo premedication will be given to Patients in the group undergoing a standardized anesthesia protocol which include induction with thiopental (5 mg/kg) and fentanyl (1-2 μg/kg). Atracurium will be used as a muscle relaxant. After tracheal intubation, anesthesia will be maintained with isoflurane in a concentration of 0.8%-1.2%. Ventilation will be adjusted to produce normocapnia. At the end of surgery, reversal of residual neuromuscular blockade will be accomplished using i.v. atropine 20 μg/Kg and neostigmine 40 μg/kg. | Drug | Control Group (III), Pre-extubation Group (II), Pre-induction Group (I) |
Primary outcome
Post Operative Nausea Vomiting assessment
Time frame: 24 hours postoperative
Nausea will be recorded according to the following scale: 0 none; 1 mild (patient able to eat); 2 moderate (oral intake significantly decreased); and 3 severe (no significant oral intake necessitating iv fluid). The absence of nausea will be defined as complete protection from nausea. An emetic episode will be defined as a single vomit or retch, or any number of continuous vomiting episodes or retches (one emetic episode should be separated from another by an absence of vomiting or retching for at least 1 min). The absence of emetic episodes will be defined as complete protection from vomiting.
3 secondary outcomes
requirements of rescue antiemetic
Time frame: 24 hours postoperative
Observer's Assessment of Alertness/ Sedation (OAA/S) scale
Time frame: 120 minutes postoperative
Pain intensity score
Time frame: 24 hours postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midazolam injection in people with Postoperative Nausea and Vomiting, run by Benha 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: finished, as of the sponsor's last update on 16 Aug 2022. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Operative Nausea Vomiting assessment (time frame: 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2022.