NCT05166330

Comparison of Different Ratios of Propofol-ketamine Admixture in Rapid-sequence Induction of Anesthesia for Emergency Laparotomy: a Randomized Controlled Trial

Status unknown Phase 4 Last updated 8 December 2021

What this trial tests

Phase 4 trial testing Ketofol equal ratio in Hypotension in 74 participants. Status unknown.

Timeline

1 December 2021

Primary endpoint
1 March 2022

1 March 2022

Quick facts

Lead sponsor	Kasr El Aini Hospital
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	74
Start date	1 December 2021
Primary completion	1 March 2022
Estimated completion	1 March 2022
Sites	1 location across Egypt

Drugs / interventions tested

• Ketofol equal ratio — full drug profile →
• Ketofol 1:3 ratio — full drug profile →

Conditions studied

• Hypotension — all drugs for Hypotension →
• Induction of Anesthesia — all drugs for Induction of Anesthesia →

Sponsor

Kasr El Aini Hospital

Who can join

Adults 18 to 65, any sex, with Hypotension or Induction of Anesthesia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• norepinephrine dose
  Time frame: 1 minute after induction of anesthesia until 15-minutes after induction
  microgram

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparison of different ratios of propofol-ketamine admixture in rapid-sequence induction of anesthesia for emergency laparotomy: a randomized controlled trial.
   Elsherbiny M, Hasanin A, Kasem S, Abouzeid M, et al · · 2023 · cited 5× · PMID 37789329 · DOI 10.1186/s12871-023-02292-w