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Clinical Trials/CTRI/2011/06/001793
CTRI/2011/06/001793RecruitingPhase 4

Changes in respiratory mechanics during extraperitoneal insufflation in inguinal hernia surgery. A preliminary study.

Department of Anaesthesiology Pain and Perioperative Medicine1 site in 1 country100 target enrollmentStarted: July 15, 2011Last updated:

Trial Snapshot

Phase
Phase 4
Status
Recruiting
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Changes in respiratory mechanics parameters viz. dynamic respiratory compliance (Cdyn) and work of breathing (WOB).

Study Overview

Brief Summary

Laparoscopy isa  commonly  performed surgical procedure wherein gasis  insufflated into the  abdominal cavity to facilitate therapeuticand diagnostic surgery via an endoscope Most laparoscopicsurgeries involve intraperitoneal insufflation of the abdominal cavity butnow   a days extraperitonealapproach for various laparoscopic procedures such as inguinal hernia repair,prostatectomy and ligation of  avaricocele is commonly employed.A large number of elderly patientswho often have preexisting cardiorespiratory disease present for laparoscopicextraperitoneal inguinal  hernia repair.

Insufflation ofthe abdominal cavity has several adverse respiratory and cardiovasculareffects. Changes in respiratory function include decrease in pulmonarycompliance , decrease in lung volumes and an increase in peak airway pressure.Major haemodynamic changes include alterations in arterial blood pressure (i.e.hypotension and hypertension), arrhythmias, increased systemic vascularresistance and decreased cardiac output.

The respiratoryand cardiovascular changes seen during intraperitoneal insufflation have beenextensively studied.Although, there are a few studies done tostudy the haemodynamic effects of extraperitoneal insufflation ,there are nosuch studies done to evaluate the effect of extraperitoneal insufflation onchanges in respiratory mechanics.

The purpose ofour study is to examine the effect of extraperitoneal insufflation on changes inrespiratory mechanics.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 75.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • American Society of Anaesthesiologists (ASA) physical status I and II
  • age group 18–75 years
  • Patients undergoing laparoscopic extraperitoneal inguinal hernia repair.

Exclusion Criteria

  • 1.Patients with pre-existing respiratory disease 2.Patients with uncontrolled hypertension and unstable coronary artery disease (CAD) 3.Patients with BMImore than 30 kg/m2.

Outcomes

Primary Outcomes

Changes in respiratory mechanics parameters viz. dynamic respiratory compliance (Cdyn) and work of breathing (WOB).

Time Frame: Time from induction of anaesthesia to end of surgery

Secondary Outcomes

  • 1. Changes in respiratory mechanics parameters viz. airway resistance (R), peak inspiratory pressure (PIP) and minute ventilation (MV)(2.Changes in haemodynamic parameters viz. heart rate and blood pressure.)

Investigators

Sponsor
Department of Anaesthesiology Pain and Perioperative Medicine
Sponsor Class
Research institution and hospital

Study Sites (1)

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