LaparoscopyPhase 4NCT05246631
Haloperidol and Dexamethasone Towards Postoperative Nausea and Pain in Adult After Laparoscopy
A Phase 4 study testing Dexamethasone injection and Haloperidol Injection in people with Laparoscopy and Postoperative Nausea and Vomiting, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This study aim to find out the effectiveness of 1 mg intravenous haloperidol compared to 5 mg intravenous dexamethasone to prevent the occurrence of nausea and vomiting also as pain control in adult patients after laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laparoscopy, Postoperative Nausea and Vomiting
- What is being tested?
- Dexamethasone injection and Haloperidol Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2020to 30 Jul 2020
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- underwent laparoscopic surgery (gynecology, digestive, or urology surgery)
- American Society of Anesthesiologist (ASA) physical status 1-3
Who cannot join
- psychological or neurological disorders (routine haloperidol consumption)
- history of allergic reaction to dexamethasone or haloperidol
- diabetes mellitus
- did not give the consent
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Central National Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: Haloperidol Compared to Dexamethasone in Lowering Postoperative Nausea and Vomiting and Pain in Adult After Laparoscopy
This study aim to find out the effectiveness of 1 mg intravenous haloperidol compared to 5 mg intravenous dexamethasone to prevent the occurrence of nausea and vomiting also as pain control in adult patients after laparoscopic surgery.
Read the detailed description
Eighty subjects (n=40 for each group) scheduled for laparoscopic-assisted surgery were enrolled in a randomized double-blind clinical trial. One milligram intravenous haloperidol was given one hour before the end of surgery, while 5 mg intravenous dexamethasone was given right after induction. The occurrence of Postoperative Nausea and Vomiting (PONV) and visual analog scale (VAS) pain score were recorded.
- Conditions
- Laparoscopy, Postoperative Nausea and Vomiting
- Being tested
- Dexamethasone injection, Haloperidol Injection
- Keywords
- dexamethasone, haloperidol, nausea, pain, vomiting
- Medical subject headings
- Postoperative Nausea and Vomiting, Nausea, Pain, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone injectionDrug
Also called dexamethasone
Group A consisted of patients given 5 mg intravenous dexamethasone after induction.
Haloperidol InjectionDrug
Also called haloperidol
Group B consisted of patients given 1 mg intravenous haloperidol one hour before the surgery ended
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Active comparator | 5 mg intravenous dexamethasone Receives: Drug: Dexamethasone injection |
| Haloperidol | Active comparator | 1 mg intravenous haloperidol Receives: Drug: Haloperidol Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nausea and Vomiting
Number of patients experiencing nausea and vomiting postoperative
Measured: Within 24 hours postoperative
Secondary outcomes (1)
Pain and VAS
Visual Analog Scale (VAS) score, the minimum score is 0 and the maximum score is 10. The higher scores mean a worse outcome
Measured: 0-2 hours, 2-6 hours, 6-12 hours, and 12-24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start1 Jan 2020
- Primary completion30 Mar 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaparoscopyStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aldy Heriwardito, Universitas Indonesia
- Investigators
- Aldy Heriwardito, Doctor, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246631
- Sponsor's protocol ID
- IndonesiaUAnes393
- Status last verified
- Feb 2022
- First submitted
- 25 Jan 2022
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haloperidol Compared to Dexamethasone in Lowering Postoperative Nausea and Vomiting and Pain in Adult After Laparoscopy
- ClinicalTrials.gov ID
- NCT05246631
- Acronym / sponsor ID
- IndonesiaUAnes393
- Conditions
- Laparoscopy, Postoperative Nausea and Vomiting
- Keywords
- dexamethasone, haloperidol, nausea, pain, vomiting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 18 Feb 2022 (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.
This study aim to find out the effectiveness of 1 mg intravenous haloperidol compared to 5 mg intravenous dexamethasone to prevent the occurrence of nausea and vomiting also as pain control in adult patients after laparoscopic surgery.
Detailed description
Eighty subjects (n=40 for each group) scheduled for laparoscopic-assisted surgery were enrolled in a randomized double-blind clinical trial. One milligram intravenous haloperidol was given one hour before the end of surgery, while 5 mg intravenous dexamethasone was given right after induction. The occurrence of Postoperative Nausea and Vomiting (PONV) and visual analog scale (VAS) pain score were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Active comparator | Drug: Dexamethasone injection5 mg intravenous dexamethasone |
| Haloperidol | Active comparator | Drug: Haloperidol Injection1 mg intravenous haloperidol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- underwent laparoscopic surgery (gynecology, digestive, or urology surgery)
- American Society of Anesthesiologist (ASA) physical status 1-3
Key exclusion criteria (4 listed)
- psychological or neurological disorders (routine haloperidol consumption)
- history of allergic reaction to dexamethasone or haloperidol
- diabetes mellitus
- did not give the consent
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 |
|---|---|---|
| Dexamethasone injectionAlso: dexamethasoneGroup A consisted of patients given 5 mg intravenous dexamethasone after induction. | Drug | Dexamethasone |
| Haloperidol InjectionAlso: haloperidolGroup B consisted of patients given 1 mg intravenous haloperidol one hour before the surgery ended | Drug | Haloperidol |
Primary outcome
Nausea and Vomiting
Time frame: Within 24 hours postoperative
Number of patients experiencing nausea and vomiting postoperative
1 secondary outcome
Pain and VAS
Time frame: 0-2 hours, 2-6 hours, 6-12 hours, and 12-24 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 18 Feb 2022.
- Individual participant dataSharing planned: Undecided
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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.
Aldy Heriwardito, Doctor principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone injection and Haloperidol Injection in people with Laparoscopy and Postoperative Nausea and Vomiting, run by Universitas Indonesia at 1 site in Indonesia.
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 2 inclusion and 4 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 18 Feb 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 Indonesia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Nausea and Vomiting (time frame: Within 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 18 Feb 2022.