Comparison of propofol and ketofol for anesthesia by intravenous route.

Phase 2

Recruiting

• Conditions: ASA Physical Status I &II

• Registration Number: CTRI/2018/01/011595
• Lead Sponsor: BJMedical College Ahmedabad

Brief Summary

Total intravenous Anesthesia is a technique in which combination of drugs are used for anesthesia via intravenous route only. Propofol is most commonly used agent till now as it provides rapid induction and faster recovery. Dose dependent cardiorespiratory depression and lack of analgesia are the main disadvantages. Ketamine provides excellent analgesia and has little or no cardiorespiratory depression. Emergence reactions is the main side effect of Ketamine. Ketofol is a combination of ketamine and propofol which is physically compatible and chemically stable. It has favorable hemodynamics, improved spontaneous ventilation andfaster recovery of postoperative cognitive function. The objective of this study is to evaluate and compare ketofol as a suitable induction agent alternative to propofol as a total intravenous anesthetic agent, hemodynamic stability, recovery of postoperative cognitive function of the patient and side effects.

Tilltoday 37 patients in ketofol group (group KP) and 31 patients in propofol(group P) group has been evaluated.

**Result**

 **Demographicdata**

**Gender** -ketofol group = 14 male and 17 female patients

propofol group = 22 male and 15female patients

**Averageage**- ketofol group 30yrs and propofol group 33 years

**Averageweight**- ketofol group 54 kg while in propofol group 55 kg

**Durationof surgery**- 37 minutes in ketofol group

in propofol group 35 minutes

**Averagefrequency of incremental dose** - ketofol group = two

propofol group = four

**Averagetotal dose of propofol** - in ketofol group = 50 mg

in propofol group = 270 mg

 **Hemodynamics**

**Pulserate**- No patients in ketofol group had fall in pulse rate. 77% patients in Propofolgroup had decreased in pulse rate (< 10% of baseline).

**Bloodpressure**- No patients in ketofol group had significant fall in both systolic &diastolic pressure. 55% patients in propofol grup had fall in blood pressure,both systolic & diastolic (20% of baseline).

 **Recovery**:

Patientsin ketofol group showed early arousal than prpofol group.

**Moodstate**- In ketofol group, patient showed more positive mood state in terms ofelation, composure, agreeable and clear headed than propofol group.

**MMSEscore**- Patients in ketofol group showed prompt recovery of cognitive function thanpropofol group.

 **Sideeffects**

1.     Incidenceapnea and hypoventilation were higher in ketofol group as compare to propofolgroup

2.     8% patients in propofol group had hypotensionand no patients in ketofol group had hypotension.

3.     7%patients in ketofol group had emergence reaction.

 **Conclusion** - Tillnow, as per results, ketofol can be an alternative to propofol for TIVA interms of hemodynamic stabilityand early recovery of cognitive function. Butketofol is associated with higher incidence of respiratory depression andemergence reaction.

 **Futuretarget**– study is still in progress and report will be updated latter.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-02
• Last Update Posted: 2018-07-16

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

ASA Physical Status I&II.

Exclusion Criteria

ASA Physical Status III, IV, V Hypersensitivity reaction to study drug, soyabean oil, glycerol, egg lrcithin Pregnant and lactating patients Patients with history of neurologic and psychiatric disease difficult airway.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pain on injection	hemodynamic parameters | pain on injection | mood status | cognitive function postoperative recovery complications likr apnea, respiratory depression, desaturation, hypotension, hypertension, bradycardia, tachycardia, nausea, vomiting
cognitive function postoperative recovery complications likr apnea, respiratory depression, desaturation, hypotension, hypertension, bradycardia, tachycardia, nausea, vomiting	hemodynamic parameters | pain on injection | mood status | cognitive function postoperative recovery complications likr apnea, respiratory depression, desaturation, hypotension, hypertension, bradycardia, tachycardia, nausea, vomiting
hemodynamic parameters	hemodynamic parameters | pain on injection | mood status | cognitive function postoperative recovery complications likr apnea, respiratory depression, desaturation, hypotension, hypertension, bradycardia, tachycardia, nausea, vomiting
mood status	hemodynamic parameters | pain on injection | mood status | cognitive function postoperative recovery complications likr apnea, respiratory depression, desaturation, hypotension, hypertension, bradycardia, tachycardia, nausea, vomiting

Secondary Outcome Measures

Name	Time	Method
hemodynamic parameters	mood status

Trial Locations

Locations (1)

B.J.Medical College & Civil Hospital, Asarwa, Ahmedabad; 🇮🇳 Ahmadabad, GUJARAT, India

B.J.Medical College & Civil Hospital, Asarwa, Ahmedabad

🇮🇳Ahmadabad, GUJARAT, India

Dr Namrata Shah

Principal investigator

9825521519

drnamrata99@yahoo.com