Comparision of two intravenous induction drugs on quality of intraoral device insertion, pulse, BP chnges and recovery
- Conditions
- Ameican society of anesthesiologist grade I,II,III grades
- Registration Number
- CTRI/2018/01/011630
- Lead Sponsor
- Government of gujarat
- Brief Summary
Propofol is a nonopioid, nonbarbiturate, sedative-hypnotic agent with rapid induction and recovery times and antiemetic effects. propofol (diprivan , 2,6-di-isopropylphenol) is most preferred induction agent for insertion of supralaryngeal device as it allows easy insertion by depressing airway reflexes. Main disadvantage with propofol is dose-related cardio-respiratory depression and pain during bolus intravenous injection.
Ketamine causes little or no cardio-respiratory depression. Its use is limited by emergence hallucinations, elevation of blood pressure and heart rate due to its sympathomimetic effects, and increased intracranial pressure.
Effectiveness of combination of propofol and ketamine (ketofol) has been recently demonstrated and may provide a novel induction agent with favorable hemodynamics and reduced side effects attributed to either drug.
**Uploaded Summary during study**
Till now 45 patients in ketofol group (group KP) and 40 patients in propofol (group P) group has been evaluated.
**Demographic data** -
**Mean age** (years): group P - 29.94, Group KP - 32.5
**Mean weight** (kg): group P - 50.02, Group KP - 52.36
**Male:female** - group P - 12:33, Group KP - 23:17
**Mean duration of Surgery** (min): group P - 33.5, Group KP - 36.5
**Mean time for loss of consciousness** (secs): group P – 43, Group KP – 37
**I gel insertion conditions**:
**Coughing/gagging**:
Nil - group KP all patients, group P 35 patients, Slight - group P 05 patients
**Jaw relaxation**:
Excellent - group KP all patients, group P 35 patients, satisfactory – group P 05 patients
**Head and neck movements**:
Nil – group KP all patients, group P 38 patients, slight – group P 02 patients
**Ease of insertion**:
Easy – group KP all patients, group P 31 patients, difficult – group P 09 patients
**Overall insertion condition**:
Excellent – group KP all patients, group P 45 patients, satisfactory – 05 patients
**Complications**:
**Pain on injection** – 30 patients in group P, 05 patients in group KP
**Hypotension** – 15 patients in group P, 05 patients in group KP
**Bradycardia** – 08 patients in group P, 03 patients in group KP
**Apnea** – 04 patients in group P, 10 patients in group KP
**Hypoventilation** - 08 patients in group P, 02 patients in group
**Study still continued**.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 100
1.ASA grade I-IV 2.Patients who required general anesthesia.
- 1.ASA status V 2.Hypersensitivity reaction to study drug, soyabean oil, glycerol, egg lecithin 3.
- Pregnant or lactating patients 4.Neonates and infants 5.Patients with history of neurologic and psychiatric diseases 6.Difficult airway.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method excellent / satisfactory / poor Appropriate size I gel or LMA will be inserted after loss of consciousness and eye lid reflex. Assessments will be done only for the first attempt. duration five minutes. Overall insertion conditions – Appropriate size I gel or LMA will be inserted after loss of consciousness and eye lid reflex. Assessments will be done only for the first attempt. duration five minutes.
- Secondary Outcome Measures
Name Time Method observing hemodynamic parameters, recovery and complications observation till end of surgery. duration of 60minutes.
Trial Locations
- Locations (1)
Civil Hospital
🇮🇳Ahmadabad, GUJARAT, India
Civil Hospital🇮🇳Ahmadabad, GUJARAT, IndiaDr Smita R EngineerPrincipal investigator9825504948seng_90@yahoo.com