NCT01182545

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2008

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

Study Start

First participant enrolled

December 1, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 17, 2010

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

November 19, 2010

Status Verified

November 1, 2010

Enrollment Period

1.7 years

First QC Date

August 12, 2010

Last Update Submit

November 18, 2010

Conditions

Laparoscopic Cholecystectomy

Keywords

Anaesthesialaparoscopic cholecystectomyCO2 insufflationhemodynamichyperventilation

Outcome Measures

Primary Outcomes (1)

  • haemodynamic percussion response

    changes in mean arterial blood pressure \[MAP\] and heart rate \[H.R\].

    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

    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,

Study Arms (2)

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.

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.

Procedure: Ventilation

Interventions

VentilationPROCEDURE

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.

The hyperventilation groupThe normoventilation group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • history of cardiovascular disease
  • respiratory diseases
  • neurological disease
  • renal disease
  • liver disease
  • hormonal disease
  • pregnancy
  • obesity (defined as a body mass index\> 29)
  • smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Faisal University

Khobar, Eastern Province, 31952, Saudi Arabia

Location

MeSH Terms

Conditions

Hyperventilation

Interventions

Ventilation

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Environment, ControlledEnvironmentEnvironment and Public Health

Study Officials

  • Mohamed R El Tahan, M.D.

    King Faisal University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 12, 2010

First Posted

August 17, 2010

Study Start

December 1, 2008

Primary Completion

August 1, 2010

Study Completion

September 1, 2010

Last Updated

November 19, 2010

Record last verified: 2010-11

Locations

SA(1)