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

This study has been completed.
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT01402622
First received: July 25, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted

July 25, 2011
July 25, 2011
December 2010
April 2011   (final data collection date for primary outcome measure)
the incidence and severity of PONV(Postoperative nausea and vomiting) [ Time Frame: 48 hours after the surgery ] [ Designated as safety issue: No ]
Comparison of the incidence and severity of PONV 48 hours after the surgery.
Same as current
No Changes Posted
Not Provided
Not Provided
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The Effect of Total Intravenous Anesthesia With Propofol on Postoperative Nausea and Vomiting in Patients Undergoing Robot-assisted Laparoscopic Radical Prostatectomy
The Effect of Total Intravenous Anesthesia With Propofol on Postoperative Nausea and Vomiting in Patients Undergoing Robot-assisted Laparoscopic Radical Prostatectomy

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.

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. Therefore, as RLRP itself can be an important risk factor of PONV, the anaesthesiologist should give attention to prevent PONV in this patient group, although they usually have lower risk in terms of patient-related factors. Previously published studies have recommended antiemetic prophylaxis for the patients with moderate-to-high risk of PONV. However, despite routine use of prophylactic antiemetics, laparoscopic surgery has been associated with higher incidence of PONV.Previous clinical studies suggested that total intravenous anaesthesia (TIVA) with propofol reduced PONV significantly compared to inhaled anaesthetics. Also, several studies have recommended TIVA with propofol as the anaesthetic method in patients with high risk of PONV. However none of these studies were designed and powered to detect differences in PONV in patients undergoing laparoscopic surgery, especially RLRP.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Robotic Radical Prostatectomy
Drug: Propofol anesthesia
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.
  • Active Comparator: Control group
    balanced anaesthesia with antiemetic prophylaxis
    Intervention: Drug: Propofol anesthesia
  • Active Comparator: TIVA group
    TIVA without antiemetic prophylaxis
    Intervention: Drug: Propofol anesthesia
  • Active Comparator: TIVA-P group
    TIVA with antiemetic prophylaxis
    Intervention: Drug: Propofol anesthesia
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
93
June 2011
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • 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).
Male
50 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01402622
4-2010-0361
No
Sun-Joon Bai / Associate Professor, Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University Health System
Yonsei University
Not Provided
Principal Investigator: Sun-Joon Bai, MD, Ph.D Severance Hospital
Yonsei University
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP