NCT01968447

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 24, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

March 16, 2020

Completed
Last Updated

March 16, 2020

Status Verified

February 1, 2020

Enrollment Period

1.7 years

First QC Date

October 7, 2013

Results QC Date

December 6, 2015

Last Update Submit

February 29, 2020

Conditions

Prostate CancerRenal Cancer

Outcome Measures

Primary Outcomes (1)

  • Surgical Rating Scale

    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.The values given on the surgical rating scale are averaged and the average value is used in the data analysis.

    Peroperative

Secondary Outcomes (6)

  • Hemodynamics

    peroperative

  • Respiratory Function

    from the end of surgery untill 2 hours postoperative

  • Pain Intensity on an 11-point Scale in the Postoperative Period

    from the end of surgery untill 2 hours postoperative

  • Sedation

    from the end of surgery untill 2 hours postoperative

  • Nausea

    from the end of surgery untill 2 hours postoperative

  • +1 more secondary outcomes

Study Arms (2)

hypocapnia

EXPERIMENTAL

arterial pCO2 of 3.5 kPa

Other: hypocapnia

normocapnia

ACTIVE COMPARATOR

arterial PCO2 of 6.5-7.0 kPa

Other: normocapnia

Interventions

hypocapniaOTHER

Hyperventilation to the level of hypocapnia

Also known as: Low CO2
hypocapnia
normocapniaOTHER

Normal ventilation to the level of nromocapnia

Also known as: normal CO2
normocapnia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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.

You may not qualify if:

  • (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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, Netherlands

Location

Related Publications (1)

  • Boon M, Martini C, Hellinga M, Bevers R, Aarts L, Dahan A. Influence of variations in arterial PCO2 on surgical conditions during laparoscopic retroperitoneal surgery. Br J Anaesth. 2016 Jul;117(1):59-65. doi: 10.1093/bja/aew114. Epub 2016 May 6.

    PMID: 27154574DERIVED

MeSH Terms

Conditions

Prostatic NeoplasmsKidney Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesUrologic NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesUrologic Diseases

Results Point of Contact

Title
Albert Dahan
Organization
LUMC
a.dahan@lumc.nl
+31 71 52 62301

Study Officials

  • Albert Dahan, MD

    LUMC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

October 7, 2013

First Posted

October 24, 2013

Study Start

February 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

March 16, 2020

Results First Posted

March 16, 2020

Record last verified: 2020-02

Locations

NL(1)