Impact of the Use of Ketamine in Laparoscopic Surgery.

NCT03724019 | Completed Phase 4 FDA Drug

• 1 other identifier: QuetaminaQOR15
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

Brief Summary

In order to improve the postoperative period (namely pain control), several drugs can be used. For instance, ketamine is a general anesthetic that holds strong analgesic properties, yet also owns undesirable effects, in which hallucination phenomena is one the most common indicator. However, slight information is available about the real implication in the quality of the recovery on the use of ketamine for postoperative pain treatment. The quality of the recovery includes several health conditions, such as pain, physical comfort, physical independence, psychological support and emotional state. In recent years, investigations in this field has been attracted the attention by the health professionals, since is an indicator of the quality of post-operative care. To evaluate these parameters, questionnaires have been developed, in which the Portuguese version of Quality of Recovery 15 (QoR-15) is include. This questionnaire evaluates five psychometric dimensions. Therefore, the present study has the main goal, the evaluation of the effect of using ketamine in laparoscopic surgery and the quality of the recovery using the QoR-15 questionnaire.

Conditions

Quality of Recovery

Keywords

Ketamine; QoR-15; Laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

• Impact in QoR-15 score

  Difference (improvement or worsening) in the postoperative baseline score (preoperative) in the Portuguese version of the Quality of Recovery questionnaire 15.

  6 months

Study Arms (2)

Group Q

EXPERIMENTAL

20 milliliter of ketamine (0.5mg / kg ideal body weight) at induction of anesthesia.

Drug: Ketamine

Group S

NO INTERVENTION

Interventions

Ketamine DRUG

Administration of 0.5mg / kg ideal body weight of ketamine at induction of anesthesia in laparoscopic surgery.

Group Q

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between 18 and 65 years age, with an American Society of Anesthesiology physical status I, II or III.
• Laparoscopic surgery (sleeve gastrectomy, salpingectomy, or cholecystectomy)

You may not qualify if:

• patient refusal, the incapacity of providing informed consent, drug abusers (current or past history) or alcohol abuse, medication with benzodiazepines, inability to give informed consent, pregnant, emergency surgery, psychiatric pathology, existence of surgical complications in the recovery and admission to a level II or III unit ( for any reason).

Sponsors & Collaborators

• Universidade do Porto: lead

Study Sites (1)

CHU São João

Porto, 4200, Portugal

Location

Related Publications (1)

• Pereira H, Graca MI, Fonseca D, Mendes-Castro A, Abelha F. Impact of Ketamine on Quality of Recovery after Laparoscopic Surgery: A Single-Centre Single-Blinded Trial Using the QoR-15 Questionnaire. Anesthesiol Res Pract. 2023 Jan 20;2023:8890025. doi: 10.1155/2023/8890025. eCollection 2023.

  PMID: 36714040 DERIVED

MeSH Terms

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: October 30, 2018
• Study Start: October 1, 2018
• Primary Completion: October 1, 2022
• Study Completion: April 1, 2023
• Last Updated: May 10, 2023

Record last verified: 2022-09

Locations

PT (1)