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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02185339
Other study ID # dNMBonResp
Secondary ID
Status Completed
Phase Phase 4
First received June 27, 2014
Last updated January 12, 2016
Start date July 2014
Est. completion date January 2015

Study information

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

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Drug:
Rocuronium
Intravenous infusion rate of rocuronium will be titrated to keep post-tetanic count between 1 to 2.
Rocuronium
Intravenous infusion rate of rocuronium will be titrated to keep train-of-four count between 1 to 2.

Locations

Country Name City State
Korea, Republic of Seoul St. Mary's Hospital Seoul

Sponsors (2)

Lead Sponsor Collaborator
Seoul St. Mary's Hospital Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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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