Comparison of Different Ratios of Propofol-ketamine Admixture in Rapid-sequence Induction of Anesthesia for Emergency Laparotomy: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- norepinephrine dose
Study Overview
Brief Summary
Hypotension during anesthesia is associated with serious organ failure and death. The most critical period for intraoperative hypotension is the postinduction period during which, one-third of intraoperative hypotension occurs. Post-induction hypotension has many contributing factors; however, it is closely related to anesthetic drugs. Therefore, manipulation of induction agents makes post-induction hypotension likely preventable. Emergency laparotomy is a critical category of surgery whose patients are usually hemodynamically compromised and prone to post-induction hypotension; furthermore, these patients are usually at high risk of aspiration of gastric contents and require rapid-sequence induction of anesthesia and optimum intubating conditions. Thus, induction of anesthesia for emergency laparotomy requires meticulous balance between achievement of adequate hypnosis and maintenance of stable blood pressure.
Propofol is the commonest hypnotic agent worldwide. However, it is usually associated with hypotension especially in compromised patients. Ketamine produces dissociative anesthesia and sympathetic stimulation which provides more stable hemodynamic profile; however, ketamine is not widely used as a routine hypnotic because it produces psychomimetic effects such as delirium and emergence agitation. Nevertheless, ketamine still has a role in induction of anesthesia in patients with shock and during procedural sedation. Ketamine is also used as analgesic adjuvant during general anesthesia.
Propofol/ketamine admixture (ketofol) was introduced in anesthetic practice aiming to compensate the side effects of the two drugs and to provide, consequently, the desired balance between adequate hypnosis and hemodynamic stability. Ketofol is currently used with a diversity in the ratio between the two drugs which ranges between 1:1 and 1:10 between ketamine and propofol. Despite its frequent use in sedation and complete anesthesia, most of the available literature for comparisons of different ketofol mixtures was restricted to procedural sedation whose results are not applicable in induction of anesthesia due to the different desirable level of hypnosis and recovery. Therefore, the best combination of the two components of ketofol for induction of anesthesia is unknown
Detailed Description
Preoperatively, a trained anesthetist will assess the patients regarding the fasting hours, medical history, medications, laboratory investigation, as well as the patient's airway.
In the operating room, routine monitors (electrocardiogram, pulse oximetry, and non-invasive blood pressure monitor) will be applied; intravenous line will be secured, and routine pre-medications (dexamethasone 4 mg as 0.5 mg/ml slow I.V injection) will be administrated. Baseline preoperative blood pressure will be recorded in the supine position as average of 3 readings with difference less than 10% in the systolic blood pressure.
After 3-minutes preoxygenation, patients in the two groups will receive 1 mg/kg lidocaine (in a separate syringe) plus 0.15-0.2 mL/kg from the prepared mixture. This regimen will provide a dose of 1 mg/kg propofol + 1 mg/kg ketamine in the ketofol-1:1 group and 1.5 mg/kg propofol + 0.5 mg/kg ketamine in the ketofol-1:3 group.
Clinical loss of consciousness (defined as no response to auditory command and the disappearance of a patient's eyelash reflex). After loss of consciousness, succinylcholine 1 mg/kg will be administered over 5 seconds, and tracheal intubation will be done through direct laryngoscopy after 60 seconds.
The intubation conditions will be graded by the same anesthetist who performed intubation as excellent, good, or poor for :ease of laryngoscopy, Vocal cord position, Reaction to insertion of the tracheal tube and cuff inflation (Diaphragmatic movement/coughing) Excellent, all criteria excellent; good, all criteria either excellent or good; poor, presence of a single criterion graded as poor.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •adult patients (18-65 years),
- •American society of anesthesiologist I-III,
- •scheduled for emergency laparotomy under general anesthesia
Exclusion Criteria
- •history of difficult intubation,
- •abnormal airway examination,
- •cardiac morbidities (impaired contractility with ejection fraction < 50%, heart block, arrhythmias, tight valvular lesions),
- •patients on angiotensin converting enzyme inhibitors and angiotensin receptor blockers medications,
- •patients with uncontrolled hypertension,
- •patient with allergy of any of the study drugs
- •Patients on vasopressor infusion,
- •patients with high shock index (heart rate / systolic blood pressure >1),
- •body mass index > 35 kg/m2, increased intracranial tension
- •pregnant women
Arms & Interventions
ketofol 1:1
0.15-0.2 mL/kg from of 5 mg/mL propofol and 5 mg/mL ketamine mixture
Intervention: Ketofol equal ratio (Drug)
Outcomes
Primary Outcomes
norepinephrine dose
Time Frame: 1 minute after induction of anesthesia until 15-minutes after induction
microgram
Secondary Outcomes
- postinduction hypotension(1 minute after induction of anesthesia until 15-minutes after induction)
- severe postinduction hypotension(1 minute after induction of anesthesia until 15-minutes after induction)
- postinduction hypertension(1 minute after induction of anesthesia until 15-minutes after induction)
- intubation condition(60 seconds after induction of anesthesia to 180 seconds after induction)
- total propofol dose(0 second after induction of anesthesia to 180 seconds after induction)
Investigators
Maha Mostafa Ahmad, MD
Principal Investigator
Kasr El Aini Hospital