Gynecological Disease
Conditions
Keywords
non-smoker, female, IV PCA, patient-controlled analgesia
Brief summary
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.
Detailed description
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).
Interventions
DRUGDexamethasone iv injection
Dexamethasone 5mg iv during anesthesia induction
DRUGDexamethasone, haloperidol
dexamethasone + haloperidol 1mg
Sponsors
The Catholic University of Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* ASA physical status I or II women * Aged 20 65 years, and scheduled for gynecologic laparoscopic surgery and IV patient-controlled analgesia (PCA) for postoperative pain control.
Exclusion criteria
* Known allergy or intolerance to the study drug * History of cardiac arrhythmia * Psychiatric illness * Chronic treatment with a dopamine antagonist * Use of opioids or steroids within one week of surgery * Use of antiemetic within 24 hours before the study * No ability to use the PCA device * Gastrointestinal, renal, or hepatic disease * Insulin-dependent diabetes or obesity with a body mass index \> 35 kg/m2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Nausea and Vomiting | postoperative 24 hours | incidence of nausea, vomiting and requirement for rescue antiemetics |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Extrapyramidal Symptoms | postoperative 24 hours | — |
| Incidence of Cardiac Arrhythmia | postoperative 2 hours | cardiac arrhythmia on continuous standard lead EKG monitoring |
| Sedation Change in Recovery Room | postoperative 30, 60, 90, and 120 min | measurement of sedation change using a visual analogue scale (visual analogue scale; the minimum: 0 = widely awake and the maximum: 10 = maximally asleep) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexamethasone dexamethasone 5mg iv during anesthesia induction
Dexamethasone iv injection: Dexamethasone 5mg iv during anesthesia induction | 50 |
| Dexamethasone, Haloperiol 1mg dexamethasone 5mg iv during anesthesia induction & haloperidol 1mg iv 30 min before end of anesthesia
Dexamethasone, haloperidol: dexamethasone + haloperidol 1mg | 49 |
| 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 | 50 |
| Total | 149 |
Baseline characteristics
| Characteristic | Dexamethasone + Haloperidol 2mg | Total | Dexamethasone | Dexamethasone, Haloperiol 1mg |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 149 Participants | 50 Participants | 49 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — | — |
| Region of Enrollment South Korea | 50 participants | 149 participants | 50 participants | 49 participants |
| Sex: Female, Male Female | 50 Participants | 149 Participants | 50 Participants | 49 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 49 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 49 | 0 / 50 |
Outcome results
Primary
Incidence of Postoperative Nausea and Vomiting
incidence of nausea, vomiting and requirement for rescue antiemetics
Time frame: postoperative 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dexamethasone | Incidence of Postoperative Nausea and Vomiting | 21 participants |
| Dexamethasone, Haloperiol 1mg | Incidence of Postoperative Nausea and Vomiting | 11 participants |
| Dexamethasone + Haloperidol 2mg | Incidence of Postoperative Nausea and Vomiting | 10 participants |
Secondary
Incidence of Cardiac Arrhythmia
cardiac arrhythmia on continuous standard lead EKG monitoring
Time frame: postoperative 2 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexamethasone | Incidence of Cardiac Arrhythmia | 0 Participants |
| Dexamethasone, Haloperiol 1mg | Incidence of Cardiac Arrhythmia | 0 Participants |
| Dexamethasone + Haloperidol 2mg | Incidence of Cardiac Arrhythmia | 0 Participants |
Secondary
Incidence of Extrapyramidal Symptoms
Time frame: postoperative 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dexamethasone | Incidence of Extrapyramidal Symptoms | 0 participants |
| Dexamethasone, Haloperiol 1mg | Incidence of Extrapyramidal Symptoms | 0 participants |
| Dexamethasone + Haloperidol 2mg | Incidence of Extrapyramidal Symptoms | 0 participants |
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)
Time frame: postoperative 30, 60, 90, and 120 min
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dexamethasone | Sedation Change in Recovery Room | postoperative 60 min | 4.4 score on a scale | Standard Deviation 1.3 |
| Dexamethasone | Sedation Change in Recovery Room | postoperative 120 min | 3.0 score on a scale | Standard Deviation 1 |
| Dexamethasone | Sedation Change in Recovery Room | postoperative 90 min | 3.5 score on a scale | Standard Deviation 1.4 |
| Dexamethasone | Sedation Change in Recovery Room | postoperative 30 min | 4.6 score on a scale | Standard Deviation 1.3 |
| Dexamethasone, Haloperiol 1mg | Sedation Change in Recovery Room | postoperative 90 min | 4.0 score on a scale | Standard Deviation 1.2 |
| Dexamethasone, Haloperiol 1mg | Sedation Change in Recovery Room | postoperative 120 min | 3.2 score on a scale | Standard Deviation 1.1 |
| Dexamethasone, Haloperiol 1mg | Sedation Change in Recovery Room | postoperative 60 min | 4.4 score on a scale | Standard Deviation 1 |
| Dexamethasone, Haloperiol 1mg | Sedation Change in Recovery Room | postoperative 30 min | 4.7 score on a scale | Standard Deviation 1 |
| Dexamethasone + Haloperidol 2mg | Sedation Change in Recovery Room | postoperative 120 min | 4.3 score on a scale | Standard Deviation 1.3 |
| Dexamethasone + Haloperidol 2mg | Sedation Change in Recovery Room | postoperative 30 min | 5.5 score on a scale | Standard Deviation 1.1 |
| Dexamethasone + Haloperidol 2mg | Sedation Change in Recovery Room | postoperative 90 min | 4.7 score on a scale | Standard Deviation 0.9 |
| Dexamethasone + Haloperidol 2mg | Sedation Change in Recovery Room | postoperative 60 min | 5.0 score on a scale | Standard Deviation 1 |