Study to Evaluate Oxygen Monitoring at Different Stages of Neuromuscular Blockade in Colorectal Surgery

NCT02327494 | Unknown DMC

• 1 other identifier: PR254/14
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Anesthesia favouring deep/intense neuromuscular blockade during laparoscopy may restore hemodynamics. However, no studies has been performed comparing oxygenation parameters during laparoscopy in colorectal surgery in either moderate or intense neuromuscular blockade. The investigators aim to investigate whether the intense neuromuscular blockade produces a better oxygenation profile measured by the central venous oxygen saturation than the moderate neuromuscular blockade. This is a one centre, prospective clinical trial to compare oxygenation data at different stages of neuromuscular blockade in high-risk patients scheduled for colorectal surgery. Data recording will be blinded to the anesthesiologist in charge of the patient, who will manage patients by a determined protocol, based on stroke volume data to direct fluidotherapy. Data analyzer will be not be involved in the study design or in writing reports from the study. Inclusion criteria: Be a candidate to a colorectal surgical resection procedure and one of these conditions: ≥ 70 y.o, or respiratory co-morbidity, or cardiac co-morbidity or haemoglobin level \< 11g/dl. The primary outcome is the absolute number of the central venous oxygen saturation, measured at the following points: basal, after tracheal intubation, before pneumoperitoneum or abdominal incision, after pneumoperitoneum or abdominal incision, 5 and 10 minutes before administration of rocuronio to produce intense blockade, continuously during profound neuromuscular blockade until the end of surgery, before sugammadex administration, after sugammadex administration, after tracheal extubation, for the 24 hours post surgical. Data of the regional cerebral oxygen saturation will be measured at the same points. The investigators hypothesize that oxygenation data will be favourable by applying the intense neuromuscular blockade in comparison with moderate neuromuscular blockade. Also, the investigators hypothesize that oxygenation data obtained during the whole procedure including the first 24-hours post-surgery, measured by the regional cerebral oxygen saturation are comparable to data obtained by the central venous oxygen saturation. The investigators want to obtain information about influence in the outcome of producing profound neuromuscular blockade during laparoscopy colorectal by comparison of outcome data with matched historical control.

Conditions

Colorectal Cancer

Keywords

Neuromuscular blockade; Laparoscopy; Oxygen measurements

Outcome Measures

Primary Outcomes (1)

• the central venous oxygen saturation (ScvO2)

  The primary objective is to study the central venous oxygen saturation (ScvO2) measured at the following points: basal, after tracheal intubation, before pneumoperitoneun or abdominal incision, after pneumoperitoneun or abdominal incision, 5 and 10 minutes before administration of rocuronium to produce intense neuromuscular blockade, continuously during profound neuromuscular blockade until the end of surgery, before sugammadex administration, after sugammadex administration, after tracheal extubation, first 24 hour postsurgery.

  intraoperative and 24 hours postoperative period

Secondary Outcomes (6)

• the central venous oxygen saturation (ScvO2)the regional cerebral oxygen saturation (rSO2)

  intraoperative and 24 hours postoperative period

• the regional cerebral oxygen saturation (rSO2)

  intraoperative and 24 hours postoperative period

• Stroke volume

  intraoperative and 24 hours postoperative period

• Fluidotherapy and Blood components transfusion

  intraoperative and 24 hours postoperative period

• pneumoperitoneum and abdominal pressures

  intraoperative and 24 hours postoperative period

Interventions

neuromuscular blockade DRUG

to determine the influence on oxygantion saturation parameters of the administration of neuromuscular blockade drug, rocuronio, to provide intense neuromuscular blockade during laparoscopic colorectal surgery

Also known as: rocuronio

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Candidates are all adult patients (over 18 y.o) on the waiting list for elective oncologic colorectal surgical resection procedure.

You may qualify if:

• Patients scheduled for elective colorectal surgery
• With one of these following conditions: ≥ 70 year old; Respiratory co-morbidity defined as: obstructive pulmonary disease diagnosed by abnormal spirometry test, alveolar-arterial oxygen differences \>15 mmHg, Sleep apnea syndrom by Eporhw criteria; Cardiac co-morbidity determined by New York functional Class II-IV; Plasmatic Hemoglobin level \< 11g/dl

You may not qualify if:

• \< 70 y.o. without respiratory or cardiac disease
• Known history of thromboembolic events in 30 days
• Known or suspected pregnancy
• Known or suspected allergy to any drug or related products used to provide anesthesia.
• Known presence of congenital disorder.
• Patients treated with aspirin, warfarin and other anti haemostatic drugs
• Contraindications to dobutamine
• Patient reluctant to participate in the trial

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (1)

Hospital Universitari de Bellvitge

Barcelona, Barcelona, 08907, Spain

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Neuromuscular Blockade; Rocuronium

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Investigative Techniques; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Antoni Sabate, MD

  Hospital Universitari de Bellvitge

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anttoni Sabate, MD

CONTACT

34-93-2607323; asabatep@bellvitgehospital.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 3, 2014
• First Posted: December 30, 2014
• Study Start: January 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: January 1, 2017
• Last Updated: January 7, 2015

Record last verified: 2015-01

Locations

ES (1)