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Low-dose haloperidol is known to be effective for the treatment of postoperative nausea and vomiting (PONV). However, precise dose-response studies have not been completed, especially in patients at high risk for PONV who require combination therapy. This study sought to identify the optimal dose of haloperidol that could be combined with dexamethasone without adverse effects in high-risk PONV patients receiving intravenous patient-controlled anesthesia (IV PCA) after gynecological laparoscopic surgery.
Female adults with three established PONV risk factors based on Apfel's score were randomised into one of three study groups. At the end of anaesthesia, groups H0, H1, and H2 were given intravenous (IV) saline, haloperidol 1 mg, and haloperidol 2 mg, respectively. All patients were given dexamethasone during the induction of anaesthesia. The overall early (0-2 h) and late (2-24 h) incidences of nausea, vomiting, rescue anti-emetic administration, pain, and adverse effects (cardiac arrhythmias and extrapyramidal effects) were assessed postoperatively. The sedation score was recorded in the postanaesthesia care unit (PACU).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dexamethasone | Placebo Comparator | dexamethasone 5mg iv during anesthesia induction |
|
| dexamethasone, haloperiol 1mg | Active Comparator | dexamethasone 5mg iv during anesthesia induction & haloperidol 1mg iv 30 min before end of anesthesia |
|
| dexamethasone + haloperidol 2mg | Active Comparator | dexamethasone 5mg iv during anesthesia induction & haloperidol 2mg iv 30 min before end of anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone iv injection | Drug | Dexamethasone 5mg iv during anesthesia induction |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Postoperative Nausea and Vomiting | incidence of nausea, vomiting and requirement for rescue antiemetics | postoperative 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Extrapyramidal Symptoms | postoperative 24 hours | |
| Incidence of Cardiac Arrhythmia | cardiac arrhythmia on continuous standard lead EKG monitoring | postoperative 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Y.E. Moon, MD | associate proffesor | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26152218 | Derived | Joo J, Park YG, Baek J, Moon YE. Haloperidol dose combined with dexamethasone for PONV prophylaxis in high-risk patients undergoing gynecological laparoscopic surgery: a prospective, randomized, double-blind, dose-response and placebo-controlled study. BMC Anesthesiol. 2015 Jul 8;15:99. doi: 10.1186/s12871-015-0081-1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexamethasone | dexamethasone 5mg iv during anesthesia induction Dexamethasone iv injection: Dexamethasone 5mg iv during anesthesia induction |
| FG001 | Dexamethasone, Haloperiol 1mg | dexamethasone 5mg iv during anesthesia induction & haloperidol 1mg iv 30 min before end of anesthesia Dexamethasone, haloperidol: dexamethasone + haloperidol 1mg |
| FG002 | Dexamethasone + Haloperidol 2mg | dexamethasone 5mg iv during anesthesia induction & haloperidol 2mg iv 30 min before end of anesthesia Dexamethasone, haloperidol: Active Comparator: dexamethasone + haloperidol 2mg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexamethasone | dexamethasone 5mg iv during anesthesia induction Dexamethasone iv injection: Dexamethasone 5mg iv during anesthesia induction |
| BG001 | Dexamethasone, Haloperiol 1mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Postoperative Nausea and Vomiting | incidence of nausea, vomiting and requirement for rescue antiemetics | Posted | Number | participants | postoperative 24 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexamethasone | dexamethasone 5mg iv during anesthesia induction Dexamethasone iv injection: Dexamethasone 5mg iv during anesthesia induction |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Young Eun Moon | Seoul St.Mary's Hospital, | 822-2258-6163 | 0910momo@naver.com |
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| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D006220 | Haloperidol |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Dexamethasone, haloperidol |
| Drug |
dexamethasone + haloperidol 1mg |
|
| Dexamethasone, haloperidol | Drug | Active Comparator: dexamethasone + haloperidol 2mg |
|
| Sedation Change in Recovery Room | measurement of sedation change using a visual analogue scale (visual analogue scale; the minimum: 0 = widely awake and the maximum: 10 = maximally asleep) | postoperative 30, 60, 90, and 120 min |
dexamethasone 5mg iv during anesthesia induction & haloperidol 1mg iv 30 min before end of anesthesia
Dexamethasone, haloperidol: dexamethasone + haloperidol 1mg
| BG002 | Dexamethasone + Haloperidol 2mg | dexamethasone 5mg iv during anesthesia induction & haloperidol 2mg iv 30 min before end of anesthesia Dexamethasone, haloperidol: Active Comparator: dexamethasone + haloperidol 2mg |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
dexamethasone 5mg iv during anesthesia induction & haloperidol 2mg iv 30 min before end of anesthesia Dexamethasone, haloperidol: Active Comparator: dexamethasone + haloperidol 2mg |
|
|
| Secondary | Incidence of Extrapyramidal Symptoms | Posted | Number | participants | postoperative 24 hours |
|
|
|
| Secondary | Incidence of Cardiac Arrhythmia | cardiac arrhythmia on continuous standard lead EKG monitoring | Posted | Count of Participants | Participants | postoperative 2 hours |
|
|
|
| Secondary | Sedation Change in Recovery Room | measurement of sedation change using a visual analogue scale (visual analogue scale; the minimum: 0 = widely awake and the maximum: 10 = maximally asleep) | Posted | Mean | Standard Deviation | score on a scale | postoperative 30, 60, 90, and 120 min |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Dexamethasone, Haloperiol 1mg | dexamethasone 5mg iv during anesthesia induction & haloperidol 1mg iv 30 min before end of anesthesia Dexamethasone, haloperidol: dexamethasone + haloperidol 1mg | 0 | 49 | 0 | 49 |
| EG002 | Dexamethasone + Haloperidol 2mg | dexamethasone 5mg iv during anesthesia induction & haloperidol 2mg iv 30 min before end of anesthesia Dexamethasone, haloperidol: Active Comparator: dexamethasone + haloperidol 2mg | 0 | 50 | 0 | 50 |
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| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D002090 | Butyrophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
|
| postoperative 90 min |
|
| postoperative 120 min |
|