- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01402622
The Effect of Total Intravenous Anesthesia With Propofol on Postoperative Nausea and Vomiting in Patients Undergoing Robot-assisted Laparoscopic Radical Prostatectomy
July 25, 2011 updated by: Yonsei University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
93
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 120-752
- Severance Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control group
balanced anaesthesia with antiemetic prophylaxis
|
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: TIVA group
TIVA without antiemetic prophylaxis
|
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: TIVA-P group
TIVA with antiemetic prophylaxis
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the incidence and severity of PONV(Postoperative nausea and vomiting)
Time Frame: 48 hours after the surgery
|
Comparison of the incidence and severity of PONV 48 hours after the surgery.
|
48 hours after the surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sun-Joon Bai, MD, Ph.D, Severance Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
July 25, 2011
First Submitted That Met QC Criteria
July 25, 2011
First Posted (Estimate)
July 26, 2011
Study Record Updates
Last Update Posted (Estimate)
July 26, 2011
Last Update Submitted That Met QC Criteria
July 25, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2010-0361
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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