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Completed

NCT Number: NCT02185339

Effects of Deep Neuromuscular Blockade on Intraoperative Respiratory Mechanics

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.

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Key information

Conditions

Laparoscopic Renal Surgery Laparoscopy Muscle Relaxation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul St. Mary's Hospital

Seoul, 137-701, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rocuronium

Drug

Intravenous infusion rate of rocuronium will be titrated to keep post-tetanic count between 1 to 2.

Other names: Esmeron®

Primary outcomes

  1. Thoracopulmonary Compliance

    Time frame: intraoperative

    Was measured with a patient spirometry monitor through a flow sensor.

    Measurements were 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).

Secondary outcomes

  1. Arterial Oxygen Tension/Inspired Oxygen Fraction

    Time frame: intraoperative

    Was calculated from arterial blood oxygen analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.

  2. Arterial to End-tidal Partial Pressure of Carbon Dioxide Difference

    Time frame: intraoperative

    Was calculated from arterial blood and expired carbon dioxide analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.

  3. Estimated Dead Space

    Time frame: intraoperative

    Was calculated from arterial blood and expired carbon dioxide analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.

  4. Pulmonary Shunt

    Time frame: intraoperative

    Was calculated using the formula: pulmonary shunt = (pulmonary capillary oxygen content - arterial oxygen content) / (pulmonary capillary oxygen content - venous oxygen content). Pulmonary capillary oxygen partial pressure is assumed to be equal to alveolar oxygen partial pressure.

    Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.

Other outcomes

  1. Stroke Volume Variation

    Time frame: intraoperative

    Was calculated by taking '(maximum stroke volume - minimum stroke volume) / mean stroke volume' over a respiratory cycle using the FloTrac™ sensor and the Vigileo™ monitor.

    Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.

  2. Cardiac Index

    Time frame: intraoperative

    Was obtained from arterial pressure waveform analysis using the FloTrac™ sensor and the Vigileo™ monitor.

    Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.

  3. Surgical Condition

    Time frame: At completion of pneumoperitoneum surgery

    Subjective rating of the view on the operating field was assessed by the surgeon who performed the surgery (optimal condition, good, acceptable, poor, extremely poor)

  4. Postoperative Pain

    Time frame: Postoperative 2 days

    Postoperative pain was measured by Visual Analogue Scale (VAS). Participants were asked to report their level of pain by pointing to a horizontal line, 10 cm in length. The scale (0-10 scores) was anchored by "no pain" (score of 0) and "pain as bad as it could be" (score of 10).

    Measurements were made at postoperative (PO) 1h, PO 2h, PO 6h, PO 24h, and PO 48h.

Sponsors and collaborators

Lead sponsor

Seoul St. Mary's Hospital

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

Effects of Deep Versus Moderate Neuromuscular Blockade on Intraoperative Respiratory Mechanics in Patients Undergoing Laparoscopic Renal Surgery: a Prospective, Randomized, Parallel Design Study

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 9, 2014
Registry last updated
Jul 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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