Two Ratios of Propofol-ketamine Admixture for Rapid-sequence Induction Anesthesia for Emergency Laparotomy

NCT05166330 | Unknown Phase 4

• 1 other identifier: MS-450-2021
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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

Conditions

Hypotension; Induction of Anesthesia

Outcome Measures

Primary Outcomes (1)

• norepinephrine dose

  microgram

  1 minute after induction of anesthesia until 15-minutes after induction

Secondary Outcomes (5)

• 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

Other Outcomes (2)

• mean arterial pressure

  1-minte before the induction, immediately after induction, immediately after intubation, then every 2-minutes for 15-minutes after induction

• heart rate

  1-minte before the induction, immediately after induction, immediately after intubation, then every 2-minutes for 15-minutes after induction

Study Arms (2)

ketofol 1:1

ACTIVE COMPARATOR

0.15-0.2 mL/kg from of 5 mg/mL propofol and 5 mg/mL ketamine mixture

Drug: Ketofol equal ratio

ketofol 1:3

ACTIVE COMPARATOR

0.15-0.2 mL/kg from of 7.5 mg/mL propofol and 2.5 mg/mL ketamine mixture

Drug: Ketofol 1:3 ratio

Interventions

Ketofol equal ratio DRUG

5mg/ml10 mL propofol (100 mg) will be mixed with 2 mL ketamine (100 mg) and then diluted to a total volume of 20 mL to have a final concentration of 5 mg/mL propofol and 5 mg/mL ketamine

ketofol 1:1

Ketofol 1:3 ratio DRUG

15 mL propofol (150 mg) will be mixed with 1 mL ketamine (50 mg) and then diluted to a total volume of 20 mL to have a final concentration of 7.5 mg/mL propofol and 2.5 mg/mL ketamine).

ketofol 1:3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients (18-65 years),
• American society of anesthesiologist I-III,
• scheduled for emergency laparotomy under general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Alaini Hospital

Cairo, 11562, Egypt

Location

Related Publications (1)

• Elsherbiny M, Hasanin A, Kasem S, Abouzeid M, Mostafa M, Fouad A, Abdelwahab Y. Comparison of different ratios of propofol-ketamine admixture in rapid-sequence induction of anesthesia for emergency laparotomy: a randomized controlled trial. BMC Anesthesiol. 2023 Oct 3;23(1):329. doi: 10.1186/s12871-023-02292-w.

  PMID: 37789329 DERIVED

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

ahmed hasanin, M.D

CONTACT

01095076954; ahmedmohamedhasanin@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 21, 2021
• Study Start: December 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: December 21, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)