The Effect of Total Intravenous Anesthesia With Propofol on Postoperative Nausea and Vomiting in Patients Undergoing Robot-assisted Laparoscopic Radical Prostatectomy

NCT01402622 | Completed Phase 4

• 1 other identifier: 4-2010-0361
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

To maximize the surgical visual field, Robot-assisted laparoscopic radical prostatectomy (RLRP) usually requires the patient to be positioned in a steep trendelenburg position in combination with prolonged intraperitoneal carbon dioxide (CO2) insufflation and increased intrabdominal pressure. Insufflations of CO2 during laparoscopic surgery, which causes stretch and irritation of the peritoneum, is known to play an important role in postoperative nausea and vomiting (PONV). In addition, prolonged pneumoperitoneum increases the risk for PONV. PONV can cause patient discomfort and prolong post anaesthesia care unit (PACU) stay. In addition, the patient with PONV is also predisposed to severe complications such as aspiration pneumonia, increased wound dehiscence, delayed recovery, prolonged hospital stay, and eventually increased medical cost.

Conditions

Robotic Radical Prostatectomy

Outcome Measures

Primary Outcomes (1)

• the incidence and severity of PONV(Postoperative nausea and vomiting)

  Comparison of the incidence and severity of PONV 48 hours after the surgery.

  48 hours after the surgery

Study Arms (3)

Control group

ACTIVE COMPARATOR

balanced anaesthesia with antiemetic prophylaxis

Drug: Propofol anesthesia

TIVA group

ACTIVE COMPARATOR

TIVA without antiemetic prophylaxis

Drug: Propofol anesthesia

TIVA-P group

ACTIVE COMPARATOR

TIVA with antiemetic prophylaxis

Drug: Propofol anesthesia

Interventions

Propofol anesthesia DRUG

In the TIVA and TIVA-P group, propofol and remifentanil were used for induction and maintenance of anaesthesia. In the control group, propofol and remifentanil were used for induction and anaesthesia was maintained with desflurane and remifentanil. In the control and TIVA-P group, ramosetron 0.3mg was administered at the end of surgery. In all patients, postoperative pain was controlled with fentanyl-based intravenous patient-controlled analgesia. he depth of anaesthesia was monitored with a bispectral index score monitor and maintained at 40-60.

Control group; TIVA group; TIVA-P group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing RLRP, ASA physical status I or II, age 50 to 70.

You may not qualify if:

• Emergency operation.
• patients with motion sickness or PONV history to control anticipated risk of PONV.
• Patients with antiemetic use within 24 hours before surgery.
• Patients with regular corticosteroid use.
• Patients with chemotherapy within 4 or radiotherapy within 8 weeks.
• Patients with allergy to any of the study drugs.
• Patients with liver dysfunction, confirmed renal impairment, or obesity (body mass index \> 35 kg/m2).

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

Study Officials

• Sun-Joon Bai, MD, Ph.D

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 25, 2011
• First Posted: July 26, 2011
• Study Start: December 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 26, 2011

Record last verified: 2011-07

Locations

KR (1)