Laparoscopy Clinical Trial
Official title:
Effects of Deep Versus Moderate Neuromuscular Blockade on Intraoperative Respiratory Mechanics in Patients Undergoing Laparoscopic Renal Surgery: a Prospective, Randomized, Parallel Design Study
Verified date | January 2016 |
Source | Seoul St. Mary's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | Interventional |
The primary objective of the current study is to compare intraoperative respiratory mechanics in patients receiving laparoscopic renal surgery under deep neuromuscular blockade (dNMB) and under moderate neuromuscular blockade (mNMB). In addition, we will compare intraoperative hemodynamics and postoperative pulmonary function between the two groups.
Status | Completed |
Enrollment | 61 |
Est. completion date | January 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - ASA I or II patients scheduled to undergo laparoscopic renal surgery Exclusion Criteria: - BMI =35 kg/m2 - Known neuromuscular disease - History of chronic obstructive pulmonary disease - Asthma - Pneumothorax - Bronchopleural fistula - Previous lung surgery - Previous retroperitoneal surgery - Hemodynamic instability - History of cardiopulmonary disease - Renal insufficiency |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul St. Mary's Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul St. Mary's Hospital | Merck Sharp & Dohme Corp. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Stroke volume variance | Will be estimated from arterial pressure waveform analysis using the FloTrac™ sensor and the Vigileo™ monitor. Measurements will be obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP. |
intraoperative | No |
Other | Cardiac index | Will be obtained from arterial pressure waveform analysis using the FloTrac™ sensor and the Vigileo™ monitor. Measurements will be obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP. |
intraoperative | No |
Other | Surgical condition | Subjective rating score of the view on the operating field assessed by the surgeon who performed the surgery (optimal condition (5), good (4), acceptable (3), poor (2), extremely poor (1)) | intraoperative | No |
Other | Postoperative pain | Visual Analogue Scale | Postoperative 2 days | No |
Primary | Thoracopulmonary compliance | Will be measured with a patient spirometry monitor through a flow sensor. Measurements will be obtained at the following four time points: (1) 15 min after a patient positioning in lateral decubitus before inducing the pneumoperitoneum (T Lateral); (2) 1 h after pneumoperitoneum induction with the patient in the lateral decubitus position (T Lat+PP1h); (3) 2 h after pneumoperitoneum induction with the patient in the lateral decubitus position (T Lat+PP2h); and (4) at the end of surgery, 15 min after abdominal deflation in the lateral decubitus position (T EndPP). |
intraoperative | No |
Secondary | Arterial oxygen tension/inspired oxygen fraction | Will be calculated from arterial blood oxygen analysis. | intraoperative | No |
Secondary | Arterial to end-tidal partial pressure of carbon dioxide difference | Will be calculated from arterial blood and expired carbon dioxide analysis. | intraoperative | No |
Secondary | Physiologic dead space | Will be calculated from arterial blood and expired carbon dioxide analysis. | intraoperative | No |
Secondary | Pulmonary shunt | Will be calculated assuming that pulmonary capillary oxygen partial pressure is equal to alveolar oxygen partial pressure. | intraoperative | No |
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