To study and comparatively evaluate the ketamine-propofol with fentanyl-propofol combination for procedural sedation and analgesia in patients undergoing laparoscopic tubal ligation and to study which drug combination leads to an earlier recovery and discharge.

Phase 2

Completed

• Conditions: surgery under anesthesia

• Registration Number: CTRI/2011/06/001850
• Lead Sponsor: lady hardinge medical college and S S K Hospital university of delhi

Brief Summary

A randomized control trial of ketamine-propofol and fentanyl-propofol combination for procedural sedation and analgesia in laparoscopic tubal ligation in ASA physical status I patients aged 18-45 years female. primary outcome measures Perioperative Hemodynamic Changes Using Ketamine-Propofol And Fentanyl-Propofol Combination For PSA In Laparoscopic Tubal Ligation. secondary outcome measures Postoperative Recovery And Duration Of Hospital Stay And Comfort And Acceptability In The Two Groups

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-11
• Last Update Posted: 2011-06-30

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Inclusion Criteria- American Society of Anesthesiologist physical status I patients aged 18-45 years female scheduled for laparoscopic tubal ligation.
• Exclusion Criteria- history of upper respiratory tract infections, asthma, allergy to propofol or ketamine, receiving treatment for psychiatric disease, receiving treatment for neuromuscular disease, seizure disorder, acid reflux, hiatus hernia, severe anemia, gross obesity, hepatic,cardiac or pulmonary disease.

Exclusion Criteria

• Inclusion Criteria- American Society of Anesthesiologist physical status I patients aged 18-45 years female scheduled for laparoscopic tubal ligation.
• Exclusion Criteria- history of upper respiratory tract infections, asthma, allergy to propofol or ketamine, receiving treatment for psychiatric disease, receiving treatment for neuromuscular disease, seizure disorder, acid reflux, hiatus hernia, severe anemia, gross obesity, hepatic,cardiac or pulmonary disease.
• Patients who have history of upper respiratory tract infections, asthma or allergy to propofol or ketamine or receiving treatment for any psychiatric or neuromuscular disease, patients with seizure disorder, acid reflux, hiatus hernia, severe anemia, gross obesity, hepatic, cardiac, or pulmonary diseases will be excluded from this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measures patient recovery time and discharge time using Ketamine-Propofol And Fentanyl-Propofol Combination For PSA In Laparoscopic Tubal Ligation.	November 2009 to March 2011

Secondary Outcome Measures

Name	Time	Method
postoperative recovery and duration of hospital stay and comfort and acceptability in the two groups	postoperative recovery and duration of hospital stay and comfort and acceptability in the two groups

Trial Locations

Locations (1)

Lady Hardinge Medical College and Associated Hospital; 🇮🇳 Delhi, DELHI, India

Lady Hardinge Medical College and Associated Hospital

🇮🇳Delhi, DELHI, India

Dr Ranju Singh

Principal investigator

9811151285

ranjusingh1503@yahoo.com