Evaluation of hemodynamic changes and patient-reported outcome measures in surgical therapy with or without intravenous sedation: a prospective controlled clinical study

Abstract

Objectives

To determine whether intravenous (IV) sedation would contribute to the stabilization of patients’ hemodynamics during periodontal and oral surgical procedures, and to evaluate the patient-reported outcome measures (PROMs).

Materials and methods

Periodontal or oral surgery patients were recruited and distributed into two groups: (1) sedation group (SG): intravenous sedation plus local anesthesia; (2) control group (CG): local anesthesia only. Systolic and diastolic blood pressure (SBP, DBP), heart rate (HR), and oxygen saturation (SaO2), were monitored at 15-min intervals from sitting in the dental chair (baseline) until the end of the treatment. In addition, a subjective assessment of PROMs was obtained through a post-operative questionnaire.

Results

Forty-nine patients (25 in SG and 24 in CG) were included. The highest SBP and DBP were significantly higher in CG compared to the SG (141.1 ± 18.4 and 133.6 ± 15.1, respectively in SBP; and 85.5 ± 11.0 and 82.9 ± 10.1, respectively in DBP), but no mean significant differences were found between groups (P value of 0.85 and 0.72 for systolic and diastolic BP, respectively). HR and SaO₂ did not show statistical intra- and inter-group differences. The overall patient satisfaction score was significantly higher in the SG group compared to CG.

Conclusions

Intravenous moderate sedation seems to contribute to the stabilization of patient’s hemodynamics, especially the systolic blood pressure, although small differences have been found.

Clinical relevance

Intravenous sedation seems to contribute to stabilize the hemodynamic values, and enhances the patient satisfaction after periodontal and oral surgical treatment in the dental office.

Appendices

Appendix A

STROBE statement—Checklist of items that should be included in reports of case-control studies

	Item no	Recommendation	Page no
Title and abstract	1	(a) Indicate the study’s design with a commonly used term in the title or the abstract	1
		(b) Provide in the abstract an informative and balanced summary of what was done and what was found	2
Introduction
Background/rationale	2	Explain the scientific background and rationale for the investigation being reported	3
Objectives	3	State specific objectives, including any prespecified hypotheses	4
Methods
Study design	4	Present key elements of study design early in the paper	4, 5
Setting	5	Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection	4
Participants	6	(a) Give the eligibility criteria, and the sources and methods of case ascertainment and control selection. Give the rationale for the choice of cases and controls	5
		(b) For matched studies, give matching criteria and the number of controls per case	5
Variables	7	Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable	6, 7
Data sources/ measurement	8*	For each variable of interest, give sources of data and details of methods of assessment (measurement). Describe comparability of assessment methods if there is more than one group	6, 7
Bias	9	Describe any efforts to address potential sources of bias	7
Study size	10	Explain how the study size was arrived at	4
Quantitative variables	11	Explain how quantitative variables were handled in the analyses. If applicable, describe which groupings were chosen and why	7
Statistical methods	12	(a) Describe all statistical methods, including those used to control for confounding	7
		(b) Describe any methods used to examine subgroups and interactions	7
		(c) Explain how missing data were addressed	7
		(d) If applicable, explain how matching of cases and controls was addressed	7
		(e) Describe any sensitivity analyses	7
Results
Participants	13*	(a) Report numbers of individuals at each stage of study—e.g., numbers potentially eligible, examined for eligibility, confirmed eligible, included in the study, completing follow-up, and analyzed	8
		(b) Give reasons for non-participation at each stage	8
		(c) Consider use of a flow diagram	Figure 1
Descriptive data	14*	(a) Give characteristics of study participants (e.g., demographic, clinical, social) and information on exposures and potential confounders	8, 9
		(b) Indicate number of participants with missing data for each variable of interest	8
Outcome data	15*	Report numbers in each exposure category, or summary measures of exposure	9
Main results	16	(a) Give unadjusted estimates and, if applicable, confounder-adjusted estimates and their precision (e.g., 95% confidence interval). Make clear which confounders were adjusted for and why they were included	8, 9
		(b) Report category boundaries when continuous variables were categorized	N/A
		(c) If relevant, consider translating estimates of relative risk into absolute risk for a meaningful time period	N/A
Other analyses	17	Report other analyses done—e.g., analyses of subgroups and interactions, and sensitivity analyses	8, 9
Discussion
Key results	18	Summarize key results with reference to study objectives	9
Limitations	19	Discuss limitations of the study, taking into account sources of potential bias or imprecision. Discuss both direction and magnitude of any potential bias	11,12
Interpretation	20	Give a cautious overall interpretation of results considering objectives, limitations, multiplicity of analyses, results from similar studies, and other relevant evidence	9,10,11
Generalisability	21	Discuss the generalisability (external validity) of the study results	11,12
Other information
Funding	22	Give the source of funding and the role of the funders for the present study and, if applicable, for the original study on which the present article is based	13

Appendix B

Corah’s Dental Anxiety Scale (DAS) 1 for preoperatory dental anxiety evaluation: (a = 1; b = 2; c = 3; d = 4; e = 5; Total possible = 20: < 9 = mild anxiety; 9–12 = moderate anxiety; 13–14 = high anxiety; 15–20 = severe anxiety (or phobia)

1. If you had to go to the dentist tomorrow for a check-up, how would you feel about it? a. I would look forward to it as a reasonably enjoyable experience b. I wouldn’t care one way or the other c. I would be a little uneasy about it d. I would be afraid that it would be unpleasant and painful e. I would be very frightened of what the dentist would do

2. When you are waiting in the dentist's office for your turn in the chair, how do you feel? a. Relaxed b. A little uneasy c. Tense d. Anxious e. So anxious that I sometimes break out in a sweat or almost feel physically sick

3. When you are in the dentist’s chair waiting while the dentist gets the drill ready to begin working on your teeth, how do you feel? a. Relaxed b. A little uneasy c. Tense d. Anxious e. So anxious that I sometimes break out in a sweat or almost feel physically sick

4. Imagine you are in the dentist’s chair to have your teeth cleaned. While you are waiting and the dentist or hygienist is getting out the instruments which will be used to scrape your teeth around the gums, how do you feel? a. Relaxed b. A little uneasy c. Tense d. Anxious e. So anxious that I sometimes break out in a sweat or almost feel physically sick