The Effects of Hyperventilation Prior to CO2 Insufflation During Laparoscopic Cholecystectomy
Primary Purpose
Laparoscopic Cholecystectomy
Status
Completed
Phase
Phase 1
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Ventilation
Sponsored by
About this trial
This is an interventional prevention trial for Laparoscopic Cholecystectomy focused on measuring Anaesthesia, laparoscopic cholecystectomy, CO2 insufflation, hemodynamic, hyperventilation
Eligibility 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
Sites / Locations
- King Faisal University
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
The normoventilation group
The hyperventilation group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
haemodynamic percussion response
changes in mean arterial blood pressure [MAP] and heart rate [H.R].
Secondary Outcome Measures
other hemodynamic and respiratory parameters
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.
Full Information
NCT ID
NCT01182545
First Posted
August 12, 2010
Last Updated
November 18, 2010
Sponsor
King Faisal University
1. Study Identification
Unique Protocol Identification Number
NCT01182545
Brief Title
The Effects of Hyperventilation Prior to CO2 Insufflation During Laparoscopic Cholecystectomy
Official Title
A Prospective Randomized Study of the Effects of Hyperventilation Prior to Carbon Dioxide Insufflation on Hemodynamic Changes During Laparoscopic Cholecystectomy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
King Faisal University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic Cholecystectomy
Keywords
Anaesthesia, laparoscopic cholecystectomy, CO2 insufflation, hemodynamic, hyperventilation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The normoventilation group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
The hyperventilation group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Ventilation
Intervention Description
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.
Primary Outcome Measure Information:
Title
haemodynamic percussion response
Description
changes in mean arterial blood pressure [MAP] and heart rate [H.R].
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
Secondary Outcome Measure Information:
Title
other hemodynamic and respiratory parameters
Description
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.
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,
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed R El Tahan, M.D.
Organizational Affiliation
King Faisal University
Official's Role
Study Director
Facility Information:
Facility Name
King Faisal University
City
Al Khubar
State/Province
Eastern
ZIP/Postal Code
31952
Country
Saudi Arabia
12. IPD Sharing Statement
Learn more about this trial
The Effects of Hyperventilation Prior to CO2 Insufflation During Laparoscopic Cholecystectomy
We'll reach out to this number within 24 hrs