comparison of two drugs for anaesthesia during dilation and curettage in females with abnormal menstrual bleeding

Not yet recruiting

• Conditions: Other specified irregular menstruation,

• Registration Number: CTRI/2023/03/050236
• Lead Sponsor: Ananta institute of medical sciences

Brief Summary

Informed consent willbe taken from each patient willing to participate in the study.  They will be allocated to one of the following two groupsas per randomization.  GroupDK(n=40):  will receive inj dexmedetomidine (0.5 mic/kg)and ketamine (1 mg/kg)  and GroupKP (n=40) : will receive inj ketamine 1mg/kg and propofol1 mg/kg diluted to total volume of 10 ml before beginning the procedure overthe period of 2 minutes. Time is recorded to achieve RSS score of 6 that will indicate onset ofsedation.  Patients are then placed inlithotomy position and procedure is started.  After completion of procedure patient is again made supine and time isrecorded till patients achieve RSS 3, and then shifted to post op area. RSS andhemodynamic parameters, Spo2 and RR are monitored every 5 min. If sedationscore is <6 then inj. Ketamine 0.5mg/kg is given as rescue drug for sedationand analgesia.

In post op area patients are shifted to ward as perAlderete criteria >9.

Duration of analgesia will be recorded for both groupsand inj diclofenac 75 mg will be used as rescue analgesia if VAS>3.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-02-24
• Study Start: 2023-03-13

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

Patients of abnormal uterine bleeding scheduled for elective endometrial sampling American Society of Anaesthesiology I and II.

Exclusion Criteria

• History of cardiovascular diseases e.g. ischemic heart disease, conduction defects, etc.
• History of compromised renal / hepatic / neuronal functions.
• Uncontrolled Hypertension and Diabetes History of alcohol, substance abuse, chronic use of analgesic and sedatives, psychiatric disorders •Patients on beta blocker or having persistent bradycardia with HR<60.
• •Drug allergy •Procedure lasting for >30 min.
• •Any surgical complications during D& C e.g. uterine perforation, excessive bleeding etc.
• •Viable Pregnancy, acute PID, undiagnosed genital tract bleeding, mass in vagina or cervix, severe arthritis hip bone, bleeding disorders, virgin females.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to onset of sedation (Ramsay sedation score RSS 6) and recovery from sedation (RSS 3)	Time to onset of sedation (Ramsay sedation score RSS 6) and recovery from sedation (RSS 3)

Secondary Outcome Measures

Name	Time	Method
1.Intraoperative Haemodynamics (Heart Rate, Blood Pressure, Spo2, Respiratory rate)	2.Post op recovery score ( Modified Aldrete Score)

Trial Locations

Locations (1)

ANANTA INSTITUTE OF MEDICAL SCIENCES; 🇮🇳 Rajsamand, RAJASTHAN, India

ANANTA INSTITUTE OF MEDICAL SCIENCES

🇮🇳Rajsamand, RAJASTHAN, India

Ankita Kaasat

Principal investigator

6361854732

ankitakaasat@gmail.com