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The Effects of Hyperventilation Prior to CO2 Insufflation During Laparoscopic Cholecystectomy

This study has been completed.
Sponsor:
Information provided by:
King Faisal University
ClinicalTrials.gov Identifier:
NCT01182545
First received: August 12, 2010
Last updated: November 18, 2010
Last verified: November 2010
  Purpose

The investigators postulated that the use of hyperventilation after induction of anesthesia before CO2 insufflation for laparoscopic surgery in Trendelenburg position would maintain normocapnia and reduce the hemodynamic percussion response of CO2 insufflation.


Condition Intervention Phase
Laparoscopic Cholecystectomy
Procedure: Ventilation
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Prospective Randomized Study of the Effects of Hyperventilation Prior to Carbon Dioxide Insufflation on Hemodynamic Changes During Laparoscopic Cholecystectomy

Resource links provided by NLM:


Further study details as provided by King Faisal University:

Primary Outcome Measures:
  • haemodynamic percussion response [ Time Frame: at 5 and 10 minutes, in supine and Trendelenburg (30° head-down) positions, respectively, before CO2 insufflation and at 15, 30, 45, and 60 min after CO2 insufflation, and at 5 min after desufflation of pneumoperitoneum ] [ Designated as safety issue: Yes ]
    changes in mean arterial blood pressure [MAP] and heart rate [H.R].


Secondary Outcome Measures:
  • other hemodynamic and respiratory parameters [ Time Frame: at 5 and 10 minutes, in supine and Trendelenburg (30° head-down) positions, respectively, before CO2 insufflation and at 15, 30, 45, and 60 min after CO2 insufflation, and at 5 min after desufflation of pneumoperitoneum, ] [ Designated as safety issue: Yes ]
    systemic vascular resistance index (SVRI), cardiac index (CI), stroke volume index (SVI), PaCO2, EtCO2, arterial to end-tidal CO2 gradient (Pa-EtCO2), respiratory rate and airway pressures were recorded.


Enrollment: 100
Study Start Date: December 2008
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: The normoventilation group
15 minutes prior to CO2 insufflation, the patients' lungs were ventilated with a tidal volume (TV) of about 8 mL.kg-1 and respiratory rate (R.R) owas adjusted to maintain an end-tidal CO2 (ETCO2) of 4.6-6 kPa throughout the procedure.
Procedure: Ventilation
Mechanical ventilation was conducted in all the patients with a Datex-Ohmeda Aestiva/5 Smart Ventilator (Madison, WI) through a rebreathing circuit incorporating a CO2 absorber, a heat and moisture exchanger using volume-controlled mode with an inspiratory to expiratory ratio of 1:2.5, and positive end-expiratory pressure (PEEP) of 5 cm H2O. Plateau pressure was kept as low as possible with an upper limit of 30 cm H2O, and the absence of auto-PEEP was ensured by a drop of the expiratory flow to zero on the flow-time curve.
Active Comparator: The hyperventilation group
15 minutes prior to CO2 insufflation, the patients' lungs were ventilated with a TV of 8 mL.kg-1 with the adjustment of the R.R to maintain an ETCO2 of 4-4.6 kPa, until the end of anaesthesia.
Procedure: Ventilation
Mechanical ventilation was conducted in all the patients with a Datex-Ohmeda Aestiva/5 Smart Ventilator (Madison, WI) through a rebreathing circuit incorporating a CO2 absorber, a heat and moisture exchanger using volume-controlled mode with an inspiratory to expiratory ratio of 1:2.5, and positive end-expiratory pressure (PEEP) of 5 cm H2O. Plateau pressure was kept as low as possible with an upper limit of 30 cm H2O, and the absence of auto-PEEP was ensured by a drop of the expiratory flow to zero on the flow-time curve.

Detailed Description:

The use of laparoscopic techniques has become common in clinical practice. Absorption of carbon dioxide (CO2) from the peritoneal cavity is the potential mechanism for hypercapnia and a rise in the end-tidal carbon dioxide (EtCO2). Mild hypercarbia causes sympathetic stimulation which results in a fivefold increase in arginine vasopressin (AVP), tachycardia, increased systemic vascular resistance, systemic arterial pressure, central venous pressure and cardiac output.1 Severe hypercarbia exerts a negative inotropic effect on the heart and reduces left ventricular function.2 Hemodynamic alterations occur only when the PaCO2 is increased by 30 per cent above the normal levels.

Clearance of CO2 is a function of the adequacy of alveolar ventilation with respect to pulmonary perfusion. Controlled hyperventilation has proved to be superior over spontaneous respiration or controlled normo-ventilation for maintaining normal PCO2 during laparoscopy. During pelvic laparoscopy there was a rapid rise of about 30% in the CO2 load eliminated by the lungs. This quickly reached a plateau and could be compensated by hyperventilation of the lungs with a 30% increase in minute ventilation.

Papadimitriou and co' workers concluded that under sevoflurane anesthesia MAC, prophylactic hyperventilation to ensure mild hypocapnia, (around 33 mmHg) limits the cerebral blood flow velocities enhancing effect of CO2 insufflation, compared with permissive hypercapnia (up to 45 mmHg), during gynecological laparoscopies. However, others advocated that hyperventilation and the head-up position before CO2 insufflation are not sufficient to prevent the CO2-mediated cerebral hemodynamic effects of low-pressure pneumoperitoneum (5-8 mmHg) in children, underwent laparoscopic fundoplication.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I & II
  • aged 18-45 years
  • undergoing elective laparoscopic cholecystectomy

Exclusion Criteria:

  • history of cardiovascular disease
  • respiratory diseases
  • neurological disease
  • renal disease
  • liver disease
  • hormonal disease
  • pregnancy
  • obesity (defined as a body mass index> 29)
  • smokers
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01182545

Locations
Saudi Arabia
King Faisal University
Al Khubar, Eastern, Saudi Arabia, 31952
Sponsors and Collaborators
King Faisal University
Investigators
Study Director: Mohamed R El Tahan, M.D. King Faisal University
  More Information

No publications provided

Responsible Party: Dr. Mohamed El Tahan, King Faisal University
ClinicalTrials.gov Identifier: NCT01182545     History of Changes
Other Study ID Numbers: 23-10-2007
Study First Received: August 12, 2010
Last Updated: November 18, 2010
Health Authority: Saudi Arabia:King Faisal University

Keywords provided by King Faisal University:
Anaesthesia
laparoscopic cholecystectomy
CO2 insufflation
hemodynamic
hyperventilation

Additional relevant MeSH terms:
Hyperventilation
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on November 24, 2014