Prophylactic Antiemetic Efficacy of Palonosetron Versus Ondansetron for the Prophylaxis of Postoperative Nausea and Vomiting (PONV) in Women Over 60 Years Undergoing Laparoscopic Cholecystectomy

NCT ID: NCT02541019

Last Updated: 2017-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-07-01

Brief Summary

Despite the development of new drugs, nausea and vomiting after surgery (PONV) are still frequent. Antagonists 5HT3 receptors, such as ondansetron and palanosetron, are among the main characterized prophylactic agents in patients at high risk, however there are few studies comparing the efficacy of these drugs and no study that addresses women aged over 60 years.

In this prospective, randomized, double-blind study, 80 women nonsmokers, undergoing laparoscopic cholecystectomy will be divided into two groups, receiving during anesthetic induction intravenous ondansetron 4 mg (n = 40) or palonosetron 75 mcg (n = 40) prophylaxis of PONV.

Detailed Description

Clinical, prospective, randomized double-blind trial will be conducted at the Federal Hospital Bonsucesso (HFB), Rio de Janeiro, Brazil. Eighty female patients, olther than 60 years, ASA I to III, undergoing laparoscopic cholecystectomy will be studied. They will be randomized into two groups of 40. One group will receive Palonosetron 75 mcg (Group P) and the other will receive Ondansetron 4mg (Group O). Patients will not receive premedication. Will be monitored in the operating room with non-invasive blood pressure, cardioscopy, pulse oximetry, capnography and bispectral index (BIS). After cannulation of peripheral vein, 10 ml of blood will be collected for further analysis. They will be given one minute before induction of anesthesia, intravenous (IV) bolus preparations of the studied antiemetics. Patients will be pre-oxygenated with oxygen at 100% for 5 minutes and the anesthetic induction is performed with intravenous administration of fentanyl 3 mcg / kg; Lidocaine 1.5 mg / kg and propofol 2 mg / kg. Tracheal intubation will be facilitated after 3 minutes of administration of Rocuronium 0.6 mg / kg EV .Maintenance of anesthesia will be with Sevoflurane 2 L / min in 50% oxygen / air, with its concentration adjusted to maintain BIS between 40-60. Remifentanil 0.05 mcg / kg / min to 0.2 mcg / kg / min IV can be administered intraoperatively if the heart rate or blood pressure to rise more than 20% of values baseline. Additional doses of rocuronium may also be administered as needed. Patients will receive paracoxibe 40 mg,dipirone 50 mg / kg and 50 mg of ranitidine IV after tracheal intubation and have the surgical wound infiltration with 20 mL of ropivacaine 0.5%, before the sutures. Neuromuscular blockade reversed with neostigmine 0.04 mg / kg and atropine 0.02 mg / kg IV at the end of surgery. Will be limited to insufflation of the pneumoperitoneum to abdominal pressure of 15 mmHg.

A non-participating physician will be aware of the research on which antiemetic was given and be responsible for postoperative prescription of patients. The researchers did not have access to prescription and medical records within 48 hours after surgery. Both groups will recive metoclopramide 10 mg (EV) as rescue medication for PONV, and the Group O will continue with prescription ondansetron 4 mg (EV) regular 8 / 8h, in the following 48 h after surgery. Patients will receive clinical visit by the research team 2, 6, 24 and 48 h after the end of surgery and will be questioned about the frequency and intensity of PONV, as well as other side effects. Finished the last evaluation, researchers will review the prescription and will note the use of opioids (type, dose, route of administration), use of rescue medication, total cost of antiemetic therapy (including 5HT3 antagonist and rescue medication), based on "Brasíndice" table.

All patients have their blood samples analyzed in the clinical research laboratory of the Universidade Federal Fluminense, for concurrent research of prevalence of polymorphisms of 5HT3 receptors and their correlation with the antiemetic effect. DNA will be extracted from blood samples using a kit to genomic DNA purification. Polymerase chain reaction test for real time will be applied below for analysis of single nucleotide polymorphisms of. The reactions are prepared with Genotyping according to the manufacturer's instructions and performed on a sequence detection system using standard thermal cycling conditions.

Conditions

Postoperative Nausea and Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Palonosetron

Palonosetron (iv) one minute before anesthesic induction.

Group Type: EXPERIMENTAL

Palonosetron

Intervention Type: DRUG

75 mcg IV, one minute before the anesthesia induction.

Ondansetron

ondansetron (iv) one minute before anesthesic induction and ondansetron regular three times a day for two days after the surgery.

Group Type: EXPERIMENTAL

Ondansetron

Intervention Type: DRUG

4 mg IV, one minute before the anesthesia induction and 4 mg IV three times a day during two days after the surgery.

Interventions

Ondansetron

4 mg IV, one minute before the anesthesia induction and 4 mg IV three times a day during two days after the surgery.

Intervention Type: DRUG

Palonosetron

75 mcg IV, one minute before the anesthesia induction.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Will be selected patients aged over 60 years, ASA 1-3 that are candidates for laparoscopic cholecystectomy

Exclusion Criteria

• Participation in another study last month.
• Body mass index> 35.
• The occurrence of episodes of nausea or vomiting in the last 24 h prior to surgery.
• Use of corticosteroids.
• Smoking.
• Alcoholism.
• Use of psychoactive drugs or any other drug with antiemetic effect.
• Known hypersensitivity to any study medication
• Severe diseases in organs such as kidney, liver, lung, heart, brain and bone marrow.
• Conversion laparoscopic cholecystectomy for conventional cholecystectomy.

• Minimum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Federal de Bonsucesso

OTHER

Sponsor Role: lead

Responsible Party

Estevão Braga

Md

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ismar L Cavalcanti, PhD

Role: PRINCIPAL_INVESTIGATOR

UFF

Locations

Hospital Federal de Bonsucesso

Rio de Janeiro, , Brazil

Countries

Brazil

References

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Other Identifiers

48149215.0.0000.5253

Identifier Type: -

Identifier Source: org_study_id