Laparoscopic CholecystectomyPhase 1NCT01182545
The Effects of Hyperventilation Prior to CO2 Insufflation During Laparoscopic Cholecystectomy
A Phase 1 study testing Ventilation in people with Laparoscopic Cholecystectomy, run by King Faisal University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- Ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Dec 2008to Sep 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA I \& II
- aged 18-45 years
- undergoing elective laparoscopic cholecystectomy
Who cannot join
- history of cardiovascular disease
- respiratory diseases
- neurological disease
- renal disease
- liver disease
- hormonal disease
Show all 9Show fewer
- pregnancy
- obesity (defined as a body mass index> 29)
- smokers
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Faisal University
Khobar, Eastern Province, 31952
About this study
Official title: A Prospective Randomized Study of the Effects of Hyperventilation Prior to Carbon Dioxide Insufflation on Hemodynamic Changes During Laparoscopic Cholecystectomy
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.
Read the 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.
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- Ventilation
- Keywords
- Anaesthesia, laparoscopic cholecystectomy, CO2 insufflation, hemodynamic, hyperventilation
- Medical subject headings
- Hyperventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VentilationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| The normoventilation group | Placebo comparator | 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. Receives: Procedure: Ventilation |
| The hyperventilation group | Active comparator | 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. Receives: Procedure: Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
haemodynamic percussion response
changes in mean arterial blood pressure [MAP] and heart rate [H.R].
Measured: 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 outcomes (1)
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.
Measured: 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,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startDec 2008
- Primary completionAug 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Faisal University
- Sponsor type
- University, hospital or other
- Investigators
- Mohamed R El Tahan, M.D., Study director, King Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182545
- Sponsor's protocol ID
- 23-10-2007
- Status last verified
- Nov 2010
- First submitted
- 12 Aug 2010
- Last updated
- 19 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study of the Effects of Hyperventilation Prior to Carbon Dioxide Insufflation on Hemodynamic Changes During Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT01182545
- Acronym / sponsor ID
- 23-10-2007
- Conditions
- Laparoscopic Cholecystectomy
- Keywords
- Anaesthesia, laparoscopic cholecystectomy, CO2 insufflation, hemodynamic, hyperventilation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- King Faisal UniversityUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 17 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The normoventilation group | Placebo comparator | Procedure: Ventilation15 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. |
| The hyperventilation group | Active comparator | Procedure: Ventilation15 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA I \& II
- aged 18-45 years
- undergoing elective laparoscopic cholecystectomy
Key exclusion criteria (9 listed)
- history of cardiovascular disease
- respiratory diseases
- neurological disease
- renal disease
- liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VentilationMechanical 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. | Procedure or surgery | The hyperventilation group, The normoventilation group |
Primary outcome
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
changes in mean arterial blood pressure [MAP] and heart rate [H.R].
1 secondary outcome
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,
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed R El Tahan, M.D. study director
King Faisal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ventilation in people with Laparoscopic Cholecystectomy, run by King Faisal University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2010.