Sedative and Analgesic Effects of Dexmedetomidine Versus Ketamine in Patients Undergoing Varicocelectomy Under Spinal Anaesthesia: A Prospective Randomized Comparative Trial

NCT07214701 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: dexmedet VS ketamine
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

Brief Summary

The demand for safe and effective sedation during spinal anesthesia has increased in recent years, particularly in ambulatory and minor surgical procedures. The ideal sedative agent should provide adequate anxiolysis and comfort, maintain cardiorespiratory stability, and allow rapid recovery without significant adverse effects . Ketamine, a phencyclidine derivative, produces sedation, analgesia, and amnesia while maintaining airway reflexes and spontaneous respiration. However, it is often associated with undesirable psychomimetic reactions and sympathetic stimulation, including tachycardia and hypertension . In contrast, dexmedetomidine, a highly selective α2-adrenergic agonist, provides cooperative sedation, analgesia, and reduced anesthetic requirements, but it may cause bradycardia and hypotension, particularly at higher doses . The combination of ketamine and dexmedetomidine (often referred to as "Ketadex") has recently gained attention due to its synergistic effects. Evidence suggests that this combination improves hemodynamic stability, decreases emergence agitation, and provides superior analgesia compared to either agent alone \[4,5\]. Moreover, ketamine counteracts the bradycardia and hypotension induced by dexmedetomidine, while dexmedetomidine mitigates ketamine-induced psychomimetic side effects . Despite these advantages, the optimal dosing regimen and comparative efficacy of the two drugs when used individually remain subjects of clinical debate. Recent randomized controlled trials comparing intravenous dexmedetomidine and ketamine during spinal anesthesia reported differences in sedation quality, hemodynamic stability, and recovery profile . Therefore, this study aims to compare the sedative and hemodynamic effects of intravenous dexmedetomidine versus ketamine infusion in patients undergoing varicocelectomy under spinal anesthesia. the study aim to Compare sedative, analgesic efficacy, and safety profile of intravenous dexmedetomidine versus ketamine in patients undergoing varicocelectomy under spinal anaesthesia

Conditions

Varicocelectomy

Outcome Measures

Primary Outcomes (1)

• the time required in minutes to achieve OAA/S score 4.

  Modified observer's assessment of alertness/sedation score (OAA/S): 5 Responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly and/or repeatedly 2 Responds only after mild prodding or shaking 1 Responds only after painful stimulus 0 No response even after painful stimulus

  24 hour

Study Arms (2)

Group A

ACTIVE COMPARATOR

patiets received Dexmedetomidine

Drug: Dexmedetomidine

Group B

ACTIVE COMPARATOR

patients receive Ketamine

Drug: Ketamine (0.5 mg/kg)

Interventions

Ketamine (0.5 mg/kg) DRUG

Intravenous infusion of ketamine 0.5 mg/kg over 10 minutes before spinal injection, diluted in 50 ml 0.9% NaCl Saline

Group B

Dexmedetomidine DRUG

Intravenous infusion of dexmedetomidine 0.25 μg/kg over 10 minutes before spinal injection, diluted in 50 ml 0.9% NaCl Saline

Group A

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: from 18 to 40 years
• Sex: Male patients
• Operation: varicocelectomy under spinal anesthesia
• ASA physical states I-II

You may not qualify if:

• Psychiatric or neurological disorders
• Respiratory disorders
• Cardiovascular disorders
• Coagulation disorders
• Contraindications to neuraxial block (allergy to L.A, peripheral issues)
• spine deformity

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Ketamine; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: residant doctor at Assiut university hospital

Study Record Dates

• First Submitted: October 5, 2025
• First Posted: October 9, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 9, 2025

Record last verified: 2025-10