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Trial record 83 of 667 for:    CARBON DIOXIDE AND arterial

Effect of Deep Neuromuscular Block and Variations in Arterial PCO2 on the Surgical Rating Scale (SRS), Following Reversal With Sugammadex (BLISSS 2)

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ClinicalTrials.gov Identifier: NCT01968447
Recruitment Status : Completed
First Posted : October 24, 2013
Last Update Posted : October 7, 2015
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Albert Dahan, Leiden University Medical Center

Brief Summary:
The purpose of this study is to study the effect of variations in the arterial CO2 concentration during deep neuromuscular block on the surgical conditions as assessed by the surgical rating scale

Condition or disease Intervention/treatment Phase
Neuromuscular Block Urologic Surgery Other: hypocapnia Other: normocapnia Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Deep Neuromuscular Block and Variations in Arterial PCO2 on the Surgical Rating Scale (SRS), Extubation Conditions and Postoperative Conditions Following Reversal With Sugammadex
Study Start Date : February 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Arm Intervention/treatment
Experimental: hypocapnia
arterial pCO2 of 3.5 kPa or 26.3 mmHg
Other: hypocapnia
Active Comparator: normocapnia
arterial PCO2 of 6.5-7.0 kPa or 48.8-52.5 mmHg
Other: normocapnia



Primary Outcome Measures :
  1. Surgical rating scale [ Time Frame: Peroperative ]
    During a procedure, the surgical condition will be scored by one surgeon using a 5-point surgical rating scale. The rating scale is a 5-point ordinal scale ranging from 1 = poor condition to 5 = optimal surgical conditions. The surgeon will score the condition at 15 minute intervals.


Secondary Outcome Measures :
  1. The relation between scoring of surgical conditions by the surgeon and video assisted scoring of surgical conditions. [ Time Frame: peroperative ]
    Video images will be collected from the camera connected to the endoscopic probe placed in the retroperitoneal field of surgery. The images collected are the images used by the surgeon to observe the surgical field throughout the procedure (these are his working images). The video images will be edited into short 1-2 min snippets at 15 min intervals (corresponding with the moment of surgical scoring). The rating scale is a 5-point ordinal scale ranging from 1 = poor condition to 5 = optimal surgical conditions. Postoperative these images will be scored by 15 anesthesiologists and 10 surgeons

  2. Hemodynamics [ Time Frame: peroperative ]
    Hemodynamic conditions are studied during low arterial CO2 concentration and normal arterial CO2 concentration.

  3. Respiratory function [ Time Frame: from the end of surgery untill 2 hours postoperative ]
    The effect of low versus normal pCO2 concentrations on the postoperative respiratory function will be studied

  4. Pain [ Time Frame: from the end of surgery untill 2 hours postoperative ]
    The effect of low versus normal pCO2 concentrations on postoperative pain will be studied

  5. Sedation [ Time Frame: from the end of surgery untill 2 hours postoperative ]
    The effect of low versus normal pCO2 concentrations on postoperative sedation will be studied using the using the validated Leiden Observer's Assessment of Alertness/Sedation (LOAA/S) scale at 15 min intervals.

  6. nausea [ Time Frame: from the end of surgery untill 2 hours postoperative ]
    The effect of low versus normal pCO2 concentrations on the incidence of postoperative nausea will be studied

  7. vomiting [ Time Frame: from the end of surgery untill 2 hours postoperative ]
    The effect of low versus normal pCO2 concentrations on the incidence of postoperative vomiting will be studied



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (i) Patients diagnosed with renal or prostatic disease who are will undergo an elective laparoscopic renal surgical procedure or laparoscopic prostatectomy;
  • (ii) ASA class I-III
  • (iii) > 18 years of age;
  • (iv) Ability to give oral and written informed consent.

Exclusion Criteria:

  • (i) Known or suspected neuromuscular disorders impairing neuromuscular function;
  • (ii) Allergies to muscle relaxants, anesthetics or narcotics;
  • (iii) A (family) history of malignant hyperthermia;
  • (iv) Women who are or may be pregnant or are currently breast feeding;
  • (v) Renal insufficiency, as defined by serum creatinine x 2 of normal, or urine output < 0.5 ml/kg/h for at least 6 h. When available, other indices will be taken into account as well such as glomerular filtration rate < 60 ml/h and proteinuria (a ratio of 30 mg albumin to 1 g of creatinine).
  • (vi) Previous retroperitoneal surgery at the site of the current surgery.
  • (vii) Body mass index > 35 kg/m2
  • (viii) Chronic obstructive pulmonary disease GOLD 2-4 or a FEV1 less than 70% predicted or VC less than 70% predicted
  • (ix) chronic pulmonary disease with altered lung physiology (eg. sarcoidosis, cycstic fibrosis, obstructing pulmonary tumors, previous lung surgery)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01968447


Locations
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Netherlands
Leiden University Medical Center
Leiden, Zuid-Holland, Netherlands
Sponsors and Collaborators
Leiden University Medical Center
Merck Sharp & Dohme Corp.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Albert Dahan, Prof. Dr., Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT01968447     History of Changes
Other Study ID Numbers: NL45461.058.13
First Posted: October 24, 2013    Key Record Dates
Last Update Posted: October 7, 2015
Last Verified: October 2015