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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

Primary Purpose

Robotic Radical Prostatectomy

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Propofol anesthesia
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Robotic Radical Prostatectomy

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Control group

TIVA group

TIVA-P group

Arm Description

balanced anaesthesia with antiemetic prophylaxis

TIVA without antiemetic prophylaxis

TIVA with antiemetic prophylaxis

Outcomes

Primary Outcome Measures

the incidence and severity of PONV(Postoperative nausea and vomiting)
Comparison of the incidence and severity of PONV 48 hours after the surgery.

Secondary Outcome Measures

Full Information

First Posted
July 25, 2011
Last Updated
July 25, 2011
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01402622
Brief Title
The Effect of Total Intravenous Anesthesia With Propofol on Postoperative Nausea and Vomiting in Patients Undergoing Robot-assisted Laparoscopic Radical Prostatectomy
Official Title
The Effect of Total Intravenous Anesthesia With Propofol on Postoperative Nausea and Vomiting in Patients Undergoing Robot-assisted Laparoscopic Radical Prostatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Robotic Radical Prostatectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
balanced anaesthesia with antiemetic prophylaxis
Arm Title
TIVA group
Arm Type
Active Comparator
Arm Description
TIVA without antiemetic prophylaxis
Arm Title
TIVA-P group
Arm Type
Active Comparator
Arm Description
TIVA with antiemetic prophylaxis
Intervention Type
Drug
Intervention Name(s)
Propofol anesthesia
Intervention Description
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.
Primary Outcome Measure Information:
Title
the incidence and severity of PONV(Postoperative nausea and vomiting)
Description
Comparison of the incidence and severity of PONV 48 hours after the surgery.
Time Frame
48 hours after the surgery

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun-Joon Bai, MD, Ph.D
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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