Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06043336 |
| Other study ID # |
FF-2018-209 |
| Secondary ID |
Fundamental data |
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
May 10, 2018 |
| Est. completion date |
May 10, 2019 |
Study information
| Verified date |
September 2023 |
| Source |
Universiti Kebangsaan Malaysia Medical Centre |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This is a prospective, randomized, double-blinded study comparing the post-operative nausea
vomiting (PONV) profile following administration of intraoperative palonosetron alone and the
combination of granisetron and dexamethasone in moderate to high-risk patients undergoing
elective laparoscopic cholecystectomy.
Patients aged 18-65 years with American Society of Anesthesiologists physical status I or II
were randomized into two groups. Group A received 1 ml of intravenous (IV) 0.9% saline after
intubation and IV palonosetron 0.075 mg at the end of operation. Group B received IV
dexamethasone 4 mg after intubation and IV granisetron 1 mg at the end of surgery. The
occurrence of PONV and the need for rescue antiemetics were assessed at 30 minutes, 4, 24 and
48 hours post-anesthesia. A complete response towards the study drugs was considered when
patients did not experience PONV and did not require rescue antiemetics. The side effects of
the study drugs were evaluated. Patient satisfaction with the anti-emetics administered was
assessed.
These parameters were compared between Group A and Group B: the occurrence of PONV, the need
of rescue antiemetics, the side effects of the study drugs and patient satisfaction with the
anti-emetics administered.
Description:
This prospective double-blinded, randomized controlled study was conducted at Hospital
Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia, Malaysia after obtaining approval
from the Institutional Ethics Committee of Universiti Kebangsaan Malaysia (UKM).
Patients aged 18 to 65 years old, American Society of Anesthesiologists (ASA) physical status
I or II, scheduled for elective laparoscopic cholecystectomy under general anesthesia were
recruited using convenient sampling. Patients with heart diseases, prolonged QT syndrome, a
family history of sudden death, known allergies, or contraindications to the study drugs were
excluded. No premedication was administered to the patients, and an intravenous (IV) drip was
not started preoperatively.
After obtaining written informed consent, patients were randomized to one of two groups using
computer-generated random numbers. Group A received IV palonosetron 0.075 mg, and Group B
received IV granisetron 1 mg and IV dexamethasone 4 mg as antiemetics.
Patients were fasted for at least 6 hours prior to surgery. In the operating room, standard
monitoring was applied to every patient, including continuous electrocardiography (ECG),
non-invasive blood pressure monitoring (NIBP), pulse oximetry, capnography with multi-gas
analyzer including minimum alveolar concentration (MAC), and monitoring of all gas levels.
Patients were pre-oxygenated with oxygen. Induction of anesthesia was conducted using IV
fentanyl 2 mcg/kg and IV propofol 2 mg/kg. Upon loss of consciousness, IV rocuronium 0.6
mg/kg was administered to facilitate endotracheal intubation, following which patients were
mechanically ventilated with a mixture of oxygen and air. Anesthesia was maintained with
sevoflurane at MAC of 1.0 to 1.2. Ventilation parameters were adjusted to maintain
normocapnia (end-tidal carbon dioxide of 35-40 mmHg) and saturation of oxygen above 96%.
Group A patients received 1 ml of IV 0.9% saline while Group B patients received IV
dexamethasone 4 mg after intubation. The amount of IV morphine given to the patients
intraoperatively was recorded and did not exceed 0.1 mg/kg. Rescue analgesia with IV fentanyl
was administered if needed, not exceeding 100 mcg. The surgeon infiltrated 10 ml of
levobupivacaine 0.5% into the incisions at the end of surgery. Patients were kept adequately
hydrated throughout the surgery with an IV drip of 2 ml/kg/h as maintenance, any fluid
deficit was replaced. Pneumoperitoneum in laparoscopic procedure was achieved by carbon
dioxide insufflation with intra-abdominal pressure of less than 14 mmHg.
Thirty minutes prior to the end of the surgery, Group A received a slow bolus of IV
palonosetron 0.075 mg, while Group B received a slow bolus of IV granisetron 1 mg.
Intravenous neostigmine 0.05 mg/kg and IV atropine 0.02 mg/kg were administered as a reversal
agent. The pneumoperitoneum was evacuated by the surgeon, and the nasogastric tube was
suctioned and removed before extubation. The patients were transferred to the recovery bay
after extubation. Rescue analgesia with IV fentanyl was administered in the recovery bay if
needed, not exceeding 50 mcg.
Patients were monitored by blinded anesthetists for nausea and vomiting in four time periods:
30 minutes, 4 hours, 24 hours, and 48 hours post-anesthesia. Nausea was defined as an
unpleasant sensation associated with the urge to vomit and its severity was rated by patients
on a scale of 0 (no nausea) to 10 (worst possible nausea). Vomiting was defined as the
forceful expulsion of gastric contents from the mouth, and the frequency of vomiting was
recorded. If a patient experienced severe nausea (nausea score of 4 and more) and vomiting,
rescue antiemetic of IV metoclopramide 10 mg was administered. Regular IV metoclopramide was
administered if the patient experienced a second episode of vomiting or more. A complete
response (free from emesis) was defined as no nausea, no vomiting and no need for any rescue
medication. Side effects of the study drugs (palonosetron, granisetron, and dexamethasone)
such as headache, constipation, dizziness, bloatedness, and palpitation were recorded. At the
end of the study, patients were asked if they were satisfied with the antiemetics given to
them. Patient satisfaction was assessed by using a Likert scale, which included a five-point
scale; very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Surgeries
that lasted more than four hours, required conversion to open cholecystectomy or other
procedures, and severe PONV that did not resolve with rescue anti-emetics were considered
dropouts in this study.
