Effects of Deep Neuromuscular Blockade on Intraoperative Respiratory Mechanics

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02185339
• Other study ID #: dNMBonResp
• 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

• Laparoscopic Renal Surgery
• Laparoscopy
• Muscle Relaxation

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