Study on the effects of sedation with Midazolam and Nitrous Oxide in Hypertensive patients during the placement of Dental Implants

The impact of sedation with midazolam and nitrous oxide versus placebo and nitrous oxide in ASA II hypertensive patients undergoing dental implant placement: a randomized, double-blind, split-mouth clinical trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-7j4tgc6

Enrollment

Unknown

Registered

2025-11-27

Start date

2025-06-17

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Essential Hypertension

Interventions

This is a two-arm, double-blind, randomized controlled clinical trial. Fifteen participants (n=15) between the ages of 25 and 80, of both genders, ASA II, hypertensive, who meet the eligibility criter

D&quot

(right side) and &quot

E&quot

(left side), respectively. In another envelope, there will be the papers corresponding to the sedation protocols: Group 1 (G1) and Group 2 (G2). Each participant will be initially randomly assigned to

Eligibility

Age

25 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients aged between 25 and 80 years; controlled hypertensive patients classified as American Society of Anesthesiologists – ASA II; patients with moderate to severe dental anxiety according to the Modified Dental Anxiety Scale (Modified Dental Anxiety Scale – MDAS); individuals indicated for rehabilitation with bilateral single-unit dental implants in the posterior mandibular region; patients of both genders

Exclusion criteria

Exclusion criteria: Chronic Obstructive Pulmonary Disease (COPD); patients classified as American Society of Anesthesiologists – ASA III; regular use of benzodiazepines; allergy or contraindication to any of the study medications; patients with uncontrolled cardiovascular diseases, severe renal insufficiency or severe hepatic insufficiency; patients using bisphosphonates; patients diagnosed with asthma; patients older than 80 years, even if meeting the inclusion criteria; any local or systemic contraindication

Design outcomes

Primary

Measure	Time frame
To evaluate and compare the control of transient arterial hypertension and pain in ASA II hypertensive patients during the installation of dental implants, using two different sedative protocols, in a randomized, double-blind, split-mouth clinical trial	—

Secondary

Measure	Time frame
Assess vital signs pre-, intra-, and postoperatively: heart rate and oxygen saturation, and identify the incidence of cardiovascular complications; compare the amount of additional local anesthetics administered between groups; assess pre- and postoperative anxiety levels; assess postoperative amnesia associated with sedation; assess the recovery of psychomotor function after the surgical procedure; and assess patient satisfaction with the procedure	—

Measure

Time frame

Assess vital signs pre-, intra-, and postoperatively: heart rate and oxygen saturation, and identify the incidence of cardiovascular complications; compare the amount of additional local anesthetics administered between groups; assess pre- and postoperative anxiety levels; assess postoperative amnesia associated with sedation; assess the recovery of psychomotor function after the surgical procedure; and assess patient satisfaction with the procedure

—

Countries

Brazil

Contacts

Public ContactMarcelo Gaspar

Universidade Santo Amaro

pesquisaunisa@unisa.br+55(11)2141-8687

Outcome results

None listed

Source: REBEC (via WHO ICTRP)